Cover of Evidence reviews for interventions to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice

Evidence reviews for interventions to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice

Maternal and child nutrition

Evidence review E

NICE Guideline, No. 247

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-6747-6
Copyright © NICE 2025.

Interventions to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice

Review question

What interventions are effective to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice for pregnant women, breastfeeding women, babies and children up to 5 years?

Introduction

The UK government recommend that women who are pregnant or breastfeeding, and babies and children under 5 years of age, take appropriate vitamin supplements to meet heightened nutritional requirements during these periods of rapid growth and development. For pregnant women the necessary supplements are folic acid and vitamin D, and breastfeeding women should take vitamin D. Vitamin D supplementation is recommended particularly during winter months, unless there are other risk factors. Under 5s should be given vitamin D from birth, and vitamins A and C from 6 months (with the exception of babies drinking more than 500ml of infant formula a day, given that this already contains vitamins). The government provides free vitamins to eligible women, babies and children under the Healthy Start scheme; including pregnant teenagers under 18 and those on very low incomes. These individuals are more likely to have poor quality diets which do not provide all the nutrients they need, and the vitamin supplements are intended to help address this. However, vitamin supplement use in line with government recommendations is generally low, including for those eligible for the Healthy Start scheme.

Understanding what interventions may be effective to increase uptake of government guidance on vitamin supplement use, including the supplements provided via Healthy Start, would enable healthcare professionals to give appropriate advice to parents and carers. The aim of this review is to find out what interventions are effective in increasing the uptake of vitamin supplements in line with government advice.

Summary of the protocol

See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.

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Table 1

Summary of the protocol (PICO table).

For further details see the review protocol in appendix A.

Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and the methods document (supplementary document 1).

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

Effectiveness evidence

Included studies

Four studies were included for this review, 2 randomised controlled trials (RCTs; de Nooijer 2012 and Evans 2014), 1 cluster randomised trial (Madar 2009), and 1 retrospective cohort study (Cawley 2020).

As per protocol studies were from high-income countries and were conducted in the USA, The Netherlands or Norway.

The included studies are summarised in Table 2.

Two studies compared interventions using information/education provision to status quo treatment (Cawley 2020 and Evans 2014), 1 study compared multicomponent interventions of information/education provision and vitamin D drops supply to status quo (Madar 2009) and 1 study compared multicomponent interventions of information/education provision and psychological or behavioural technique (implementation intention instruction) to information/education provision only (de Nooijer 2012).

One study included a population of pregnant and postpartum women (Cawley 2020), 1 study included pregnant women only (Evans 2014), 1 study examined outcomes in children aged between 1 and 5 years (de Nooijer 2012) and 1 study examined outcomes in babies from birth to 1 year (Madar 2009).

Three studies reported on the critical outcome changes in vitamin supplementation uptake rate (Cawley 2020, de Nooijer 2012 and Madar 2009) and 1 study reported on the important outcome changes in attitudes, confidence and knowledge as part of people’s intention to change behaviour (with a focus on attitudes) (Evans 2014). No evidence was found that reported on the important outcome unintended consequences as it relates to increase in inequalities and supplementation wastage.

Meta-analysis was not performed as the studies had different interventions/comparisons or they did not report the same outcome of interest.

Sensitivity analysis on the following component domains along with the interventions were planned if there was enough data available: component 1 mode of delivery, component 2 intervention aimed at individuals or groups, component 3, individualised/tailored interventions or general, component 4 who delivers the intervention, component 5 where the intervention is delivered, component 6 behaviour change models, techniques and theories. However, sensitivity analysis could not to be performed by component as there were not more than two studies per analysis.

None of the studies reported information on any of the subgroups prespecified in our protocol: Women and parents with disabilities, including learning disabilities and other physical and mental health conditions; women going through assisted conception; LGBTQ+ women and parents; children with developmental problems; geographical variation, for example, places without adequate provision of primary care (outside cities).

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review are listed, and reasons for their exclusion are provided in appendix J.

Summary of included studies

Summaries of the studies that were included in this review are presented in Table 2.

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Table 2

Summary of included studies.

See the full evidence tables in appendix D. No meta-analysis was conducted (and so there are no forest plots in appendix E).

Summary of the evidence

Comparison 1: Interventions using information/education provision versus status quo (including no treatment) in pregnant women– Combined components

Two studies were included in this comparison. Results from 1 study in pregnant women showed that interventions using general information/education provision, delivered using digital/electronic interventions, aimed at individuals, delivered by peer and delivered on mobile devices showed no important difference for prenatal vitamin supplementation uptake in pregnant women when compared with status quo. Results from 1 study in pregnant women showed that interventions using general information/education provision, delivered using face to face and digital/electronic interventions, aimed at individuals, delivered by peer, on mobile devices and based on the health belief model and social cognitive theory showed an important benefit over status quo for change in attitudes towards prenatal vitamins in pregnant women based on the statement "Strongly agree that taking a prenatal vitamin will improve the health of my developing baby". However, there was no evidence of important differences found between the same intervention and comparator group for attitudes reflecting the statement "Strongly agree that taking a prenatal vitamin is important to the health of my developing baby".

The quality of the evidence was very low.

Comparison 2: Multicomponent interventions (information/education provision and Vitamin D drops supply) versus status quo (including no treatment) in babies aged 3 months– Combined components

One study in babies aged 3 months was included in this comparison. Multicomponent interventions involving general information/education provision and supply of vitamin D drops delivered using face to face and printed interventions, aimed at individuals and delivered by public health nurses in child health clinics showed an important benefit over status quo for vitamin D supplementation uptake rate in babies aged 3 months.

The quality of the evidence was very low.

Comparison 3: Multicomponent interventions (information/education provision and psychological or behavioural technique) versus control (information/education provision only) in children 1 to 3.5 years– Combined components

One study in children 1 to 3.5 years was included in this comparison. Multicomponent interventions involving general information/education provision and psychological or behavioural technique, delivered using face to face and printed interventions, aimed at individuals and delivered on an internet panel showed no evidence of important difference over information/education provision only for vitamin D supplementation uptake rate in children aged 1 to 3.5 years.

The quality of the evidence was low.

See appendix F for full GRADE tables.

Economic evidence

Included studies

Three economic studies were identified which were relevant to this question (Filby 2014, Filby 2015, Floreskul 2020). There was also one study reporting utility data that was identified in this review (Aguiar 2020), which could be used in economic modelling.

See the literature search strategy in appendix B and economic study selection flow chart in appendix G.

Excluded studies

Economic studies not included in this review are listed, and reasons for their exclusion are provided in appendix J.

Summary of included economic evidence

See Table 3 and Table 4 for the economic evidence profiles of the included studies.

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Table 3

Economic evidence profile for interventions aiming to increase uptake of vitamin D in pregnant women, infants and children up to 5 years of age.

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Table 4

Economic evidence profile for intervention aiming to increase uptake of Healthy Start vitamin programme in women planning a pregnancy, pregnant women, infants and children up to 5 years of age.

Economic model

This area was prioritised for de novo economic modelling. The committee selected to assess the cost-effectiveness of health technologies (such as apps), because these are the only interventions they considered for a recommendation which have promising evidence but are not currently in routine use in England. However, there was no adequate effectiveness evidence on health technologies to allow a meaningful and informative economic analysis to be carried out. Therefore, no economic model was developed for this review question.

Economic evidence statement

  • Evidence from 1 UK modelling study was unclear as to whether free vitamin D supplementation and information aiming to increase uptake of vitamin D to pregnant women up to 12 months post-partum and children aged <5 years was cost-effective versus no intervention, as the study did not use the QALY as the measure of outcome, so it was difficult to assess whether additional benefits (number of people taking vitamin D supplements and number of people with symptomatic vitamin D deficiency averted) were worth the extra costs incurred. The evidence is partially applicable to the NICE decision-making context as the study it did not use the QALY as the measure of outcome, and is characterised by potentially serious limitations.
  • Evidence from 1 UK modelling study suggests that, compared with no intervention, free vitamin D supplementation to pregnant women and children <4 years of age is likely to be cost-effective if the study population has dark skin tone, may be cost-effective if the study population has medium skin tone, but is highly unlikely to be cost-effective if the study population has light skin tone. The evidence is directly applicable to the UK context and is characterised by potentially serious limitations.
  • Evidence from 1 UK modelling study suggests that universal offering of the Healthy Start Vitamin programme to pregnant women from 10 weeks, women with a child aged <12 months, and children aged 6 months - 4 years is not cost-effective compared with the current offering of Healthy Start Vitamin programme (which involves pregnant women from 10 weeks aged <18 years, low-income adult pregnant women from 10 weeks, low-income women with a child aged <12 months, and children from low-income families aged 6 months - 4 years). On the other hand, universal offering of the Healthy Start Vitamin programme and extension to all women planning a pregnancy, all pregnant women regardless of month in pregnancy, women with a child aged <12 months, infants aged 0-6 months and children aged 6 months – 5 years is likely to be cost effective compared with the current offering of Healthy Start Vitamin programme. Universal offering of the Healthy Start Vitamin programme is particularly cost-effective when it is focused to all women planning a pregnancy and pregnant women within 10 weeks into pregnancy. The evidence is directly applicable to the UK context but is characterised by potentially serious limitations.

The committee’s discussion and interpretation of the evidence

The outcomes that matter most

Changes in vitamin supplementation uptake rate was prioritised as the critical outcome by the committee because it is the most appropriate measure that directly answers the review question. The committee considered that both subjective and objective measures of vitamin supplementation uptake will be useful to determine the effectiveness of interventions aimed at improving uptake of vitamins in line with government advice.

The committee agreed that changes in attitude, confidence and knowledge as part of people’s intention to change behaviour and unintended consequences such as supplementation wastage and increase in inequalities should be important outcomes. This was because they are common factors to measure and target in an intervention and can ultimately impact on behaviour. In addition, inequalities are reported as part of the studies on Healthy Start in England.

No evidence was found that reported on the outcome unintended consequences.

The quality of the evidence

The quality of the evidence for outcomes was assessed using GRADE and the majority of the evidence was very low in quality. The main issues with the quality were due to bias arising from the methodological quality of the studies, indirect interventions due to broader intervention aims than the protocol for this review and imprecision.

Individual studies were assessed for methodological quality based on their study design. Randomised controlled trials were assessed using the Cochrane RoB 2.0 tool, cluster randomised studies were assessed using the Cochrane RoB 2.0 tool for cluster randomised trials and retrospective cohort studies were assessed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool. Concerns towards risk of bias for randomised control trials related to attrition, randomisation process, concealment of allocation, outcome measurement and analysis method. Concerns towards risk of bias for the cluster randomised trial related to measurement of outcome and missing outcome data. Concerns towards risk of bias for the retrospective cohort studies primarily related to retrospective classification of intervention groups, unclear details on initiation, adherence and deviations from intended interventions and unclear bias in selection of reported results.

Benefits and harms

The committee considered the current government advice from the Scientific Advisory Committee on Nutrition (SACN) for vitamins uptake in the different populations included in the review – pregnant women, breastfeeding women, babies <1 year and children between 1 and 5 years and agreed that all health professionals working with any of these populations should provide the key messages from the government advice on vitamins intake during pregnancy, breastfeeding and in children from birth to 5 years (SACN 2016). The committee discussed that it is crucial to increase awareness on the importance of vitamin supplements in various settings as all these contacts would provide opportunities to counsel women about the benefits of vitamins for themselves and their babies and young children. In the evidence, this information was discussed during antenatal care, appointments or checks or at baby development check. The committee agreed that this setting and time point was appropriate for providing information and also used the qualitative evidence (see evidence report P) to suggest additional timepoints and settings for this to occur such as during antenatal and postnatal care appointments or checks, vaccination appointments (during pregnancy and after birth), at pharmacies, appointments in specialist clinics for pre-existing medical conditions (such as diabetes or epilepsy), within multi-agency health and social care hubs, at visits to young people’s services and at breastfeeding support group sessions.

The committee discussed that the available evidence did not show much benefit towards the use of digital or electronic means for providing information to pregnant women. While the committee noted from their experience that there is an increased use of digital technology for providing information, they did not make any recommendations towards digital technologies based on the limited low quality evidence. The committee agreed not to prioritise this topic for a research recommendation but made a related research recommendation on digital technologies to increase uptake of folic acid before and during pregnancy, see evidence review C for more details. The evidence showed that there was an important benefit in improving uptake of vitamin D in children with the use of face-to-face information provision/education and provision of leaflets when compared with status quo treatment. As there was no robust evidence on different modes of delivery, the committee agreed that the information could be delivered in different formats depending on feasibility and the person’s preference.

The committee discussed the low-quality evidence on behavioural intervention combined with providing information or education materials in relation to formulating an implementation intention for increasing uptake of vitamins in children. This showed no evidence of important difference and the committee agreed that no specific recommendation can be made in relation to behavioural interventions. The committee discussed techniques in the evidence that served as a helpful reminder to take vitamins. These included pairing a behaviour with a routine activity such as bedtime story or reminder through apps and in combination with the evidence from the qualitative report (evidence report P) came to the consensus that the health care provider should discuss ways to remember taking vitamin supplements each day.

The committee discussed current government advice on vitamin D supplementation. All pregnant or breastfeeding people are advised to take vitamin D supplement during the autumn and winter months when sunlight is not sufficient in the UK setting to provide enough vitamin D. However, vitamin D supplementation throughout the year is advised for people with reduced sun exposure, such as those who are not outdoors often or frequently cover their skin and people who are at a higher risk of not making sufficient vitamin D from sunlight, such as people with darker or medium skin tones. The committee wanted to highlight in the recommendations that the risk of vitamin D insufficiency during pregnancy may be increased in these populations. All young children are advised to take vitamin D supplementation throughout the year, except for infants who receive at least 500ml of formula milk per day.

There was very low-quality evidence on giving information along with supply of vitamin D drops for children that showed an important benefit. There was no clinical evidence found for interventions aimed at improving access to vitamin supplementation for pregnant or breastfeeding women or children. Evidence from an economic study among pregnant and breastfeeding women and their children showed free vitamin D provision to those with medium to dark skin to be cost-effective in preventing vitamin D deficiency and rickets. Based on the evidence the committee agreed that services should offer free vitamin D supplements for children under 5 years, pregnant and breastfeeding women if they are at increased risk of vitamin D deficiency because of their skin tone or because of lack of exposure to sunlight.

The committee discussed the free vitamin supplements that are offered to pregnant or breastfeeding people or children through the Healthy Start Scheme and agreed it is important that healthcare professionals discuss and provide information about the scheme, what the supplements contain, and refer people to the scheme if appropriate.

The committee also discussed eligibility in relation to free Healthy Start vitamins. The committee noted that Healthy Start scheme is income derived for those over 18 years of age (while all pregnant and/or breastfeeding teenagers under 18 are eligible) such that an individual needs to be in receipt of specific benefits to be eligible. However, the committee were aware that Healthy Start vitamins were already available free of charge in some areas regardless of the family’s income or their risk of vitamin D deficiency.

The committee came to the consensus that for households not eligible for free Healthy Start vitamins, advice should be provided in line with government advice. In addition, the committee came to the consensus that pregnant and breastfeeding people who are eligible for Healthy start vitamins should follow government advice on dosage, products or supplements to avoid (Healthy Start vitamins and NHS advice on vitamins, supplements and nutrition in pregnancy). The committee also discussed the needs of individuals who may be following a restricted diet, such as vegan or gluten-free diet, and came to the consensus that, following government advice, this population may also need to take a vitamin B12 supplement (NICE guideline on vitamin B12 deficiency in over 16s, NHS advice on being vegetarian or vegan and pregnant and NHS advice on B vitamins).

The committee discussed that in line with government advice (UK government advice about vitamins for babies and vitamins for children), health care professionals should provide information and advice to parents and carers on vitamin supplementation such as which vitamins should be given and at what age, and how that is impacted if the baby is formula fed, and where to get the supplements.

All available evidence was in those with single pregnancies. There was no evidence for women with multiple pregnancies, hence the committee did not make any specific recommendations for this group. The committee referred to the section on diet, lifestyle and nutritional supplements in the NICE guideline on Twin and triplet pregnancy, as this provides advice on nutritional supplements for multiple pregnancies.

Cost effectiveness and resource use

There was UK evidence that offering Healthy Start supplements universally to the current target group (pregnant women from 10 weeks, women with a child aged under 12 months and children over 6 months and under 4 years) was not cost-effective; however, if universal offering was extended to women who are planning a pregnancy, women less than 10 weeks pregnant, infants aged 0–6 months and children aged from 4 to 5 years, then it became cost-effective as it increased vitamin uptake, but only if the cost per head of including women planning a pregnancy and those who are less than 10 weeks pregnant was not considerably higher than the cost per head for women already in the scheme. However, a mechanism would need to be identified to deliver a universal scheme to these 2 groups, which would require a new route to target women this early on.

There was evidence from a recent UK study that free vitamin D supplementation to pregnant women and children up to 4 years of age with darker or medium tone skin (who are at higher risk for vitamin D deficiency) is cost-effective, by reducing the risk of vitamin D deficiency and, consequently, reducing the risk of developing rickets in children. In contrast, free vitamin D supplementation to a respective population with light tone skin was not cost-effective. The review question was originally prioritised for economic modelling, as the committee wished to assess the cost-effectiveness of health technologies in enhancing uptake of vitamins. However, clinical evidence around health technologies was too limited and uncertain to inform an economic model. The recommendations made overall reflect current practice and aim to reiterate government advice and harmonise practice across settings, by providing advice during routine or other planned appointments. Moderate resource implications (in terms of health professionals’ time) are expected in settings where optimal advice on vitamin supplementation is currently not offered or is limited. The recommendation to offer free vitamin D supplements for women and people who are pregnant or breastfeeding, and for children under 5 years of age, if they have darker skin or limited exposure to sun, may also have small to moderate resource implications to settings where this is not current practice, comprising the acquisition cost of the vitamin supplements. However, as reported above, offering free vitamin D supplementation to a population of pregnant women and children up to 4 years of age who have darker skin (and are thus at a higher risk for vitamin D deficiency) was found to be cost-effective in the UK, as it reduced the risk of rickets in children and therefore led to clinical benefits for the children and future cost-savings to the NHS. The recommendation was not expanded to the respective population with light skin tone because evidence suggested that this was highly unlikely to be cost-effective, due to this population’s lower risk of vitamin D deficiency and, subsequently, for development of rickets in children.

Other factors the committee took into account

For this review question, in relation to vitamin supplementation during or after pregnancy, the population in the evidence was women and no evidence was identified or reviewed for trans men or non-binary people. The protocol and literature searches were not designed to specifically look for evidence on trans men or non-binary people but they were also not excluded. However, there is a small chance evidence on them may not have been captured, if such evidence exists. In discussing the evidence, the committee considered whether the recommendations could apply to a broader population, and used gender inclusive language to promote equity, respect and effective communication with everyone. Healthcare professionals should use their clinical judgement when implementing the recommendations, taking into account each person’s circumstances, needs and preferences, and ensuring all people are treated with dignity and respect throughout their care.

Recommendations supported by this evidence review

This evidence review supports recommendations 1.1.10 to 1.1.14. Other evidence supporting these recommendations can be found in the evidence review P on facilitators and barriers to increase the uptake of government advice on folic acid and vitamin supplements.

References – included studies

    Effectiveness

    • Cawley 2020

      Cawley, Caroline, Buckenmeyer, Hannelore, Jellison, Trina et al. Effect of a Health System-Sponsored Mobile App on Perinatal Health Behaviors: Retrospective Cohort Study. JMIR mHealth and uHealth 8(7): e17183, 2020 [PMC free article: PMC7380997] [PubMed: 32628123]

    • de Nooijer 2012

      de Nooiier, J.; Jansen, R.; van Assema, P. The use of implementation intentions to promote vitamin D supplementation in young children. Nutrients 4(10): 1454–1463, 2012 [PMC free article: PMC3497004] [PubMed: 23201764]

    • Evans 2014

      Evans, WD, Wallace Bihm, J, Szekely, D et al. Initial outcomes from a 4-week follow-up study of the Text4baby program in the military women’s population: randomized controlled trial. Journal of medical Internet research 16(5): e131, 2014 [PMC free article: PMC4051747] [PubMed: 24846909]

    • Madar 2009

      Madar AA; Klepp K; Meyer HE. Effect of free vitamin D(2) drops on serum 25-hydroxyvitamin D in infants with immigrant origin: a cluster randomized controlled trial. Eur J Clin Nutr 63(4): 478–84, 2009 [PubMed: 18231120]

    Economic

    • Aguiar 2020

      Aguiar M, Andronis L, Pallan M, Högler W, Frew E (2020). Micronutrient deficiencies and health-related quality of life: the case of children with vitamin D deficiency. Public Health Nutr, 23(7), 1165–1172. [PMC free article: PMC10200666] [PubMed: 30744725]

    • Filby 2014

      Filby A, Lewis L, Taylor M. National Institute for Health and Care Excellence. An Economic Evaluation of Interventions to Improve the Uptake of Vitamin D Supplements in England and Wales. Report. York Health Economics Consortium, 2014.

    • Filby 2015

      Filby A, Taylor M, Jenks M, Burley V. National Institute for Health and Care Excellence. Examining the cost-effectiveness of moving the Healthy Start Vitamin Programme from a targeted to a universal offering. Final report. York Health Economics Consortium, 2015.

    • Floreskul 2020

      Floreskul V, Juma FZ, Daniel AB, Zamir I, Rawdin A, Stevenson M, Mughal Z, Padidela R (2020). Cost-Effectiveness of Vitamin D Supplementation in Pregnant Woman and Young Children in Preventing Rickets: A Modeling Study. Front Public Health, 8:439. [PMC free article: PMC7498641] [PubMed: 33014962]

    Other

Appendices

Appendix E. Forest plots

Forest plots for review question: What interventions are effective to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice for pregnant women, breastfeeding women, babies and children up to 5 years?

No meta-analysis was conducted for this review question and so there are no forest plots.

Appendix I. Economic model

Economic model for review question: What interventions are effective to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice for pregnant women, breastfeeding women, babies and children up to 5 years?

This area was prioritised for de novo economic modelling. The committee selected to assess the cost-effectiveness of health technologies (such as apps), because these are the only interventions they considered for a recommendation which have promising evidence but are not currently in routine use in England. However, there was no adequate effectiveness evidence on health technologies to allow a meaningful and informative economic analysis to be carried out. Therefore, no economic model was developed for this review question.

Appendix J. Excluded studies

Excluded studies for review question: What interventions are effective to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice for pregnant women, breastfeeding women, babies and children up to 5 years?

Excluded effectiveness studies

The excluded studies table only lists the studies that were considered and then excluded at the full-text stage for this review (N=17) and not studies (N=42) that were considered and then excluded from the search at the full-text stage as per the PRISMA diagram in Appendix C for the other review question in the same search (see evidence review C).

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Table 11

Excluded studies and reasons for their exclusion.

Excluded economic studies

Appendix K. Research recommendations – full details

Research recommendations for review question: What interventions are effective to increase uptake of vitamin supplements (including Healthy Start vitamins) in line with government advice for pregnant women, breastfeeding women, babies and children up to 5 years?

No research recommendations were made for this review question.