Influence of vitamin D supplementation on growth, body composition, pubertal development and spirometry in South African schoolchildren: a randomised controlled trial (ViDiKids)
ABSTRACT Objective To determine whether weekly oral vitamin D supplementation influences growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.Design Phase 3 double-blind randomised placebo-controlled trial (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">clinicaltrials.gov</jats:ext-link>registration no.<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT02880982">NCT02880982</jats:ext-link>).Setting Socio-economically disadvantaged peri-urban district of Cape Town, South AfricaParticipants 1682 children of Black African ancestry attending government primary schools and aged 6-11 years at baseline.Interventions Oral vitamin D3(10,000 IU/week) vs. placebo for 3 yearsMain outcome measures height-for-age and body mass index-for-age, measured in all participants); Tanner scores for pubertal development, spirometric lung volumes and body composition, measured in a subset of 450 children who additionally took part in a nested sub-study.Results Mean serum 25-hydroxyvitamin D3concentration at 3-year follow-up was higher among children randomised to receive vitamin D vs. placebo (104.3 vs. 64.7 nmol/L, respectively; mean difference [MD] 39.7 nmol/L, 95% CI 37.6 to 41.9 nmol/L). No statistically significant differences in height-for-age z-score (adjusted MD [aMD] −0.08, 95% CI −0.19 to 0.03) or body mass index-for-age z-score (aMD −0.04, 95% CI −0.16 to 0.07) were seen between vitamin D vs. placebo groups at follow-up. Among sub-study participants, allocation to vitamin D vs. placebo did not influence pubertal development scores, % predicted forced expiratory volume in 1 second (FEV1), % predicted forced vital capacity (FVC), % predicted FEV1/FVC, fat mass or fat-free mass.Conclusions Weekly oral administration of 10,000 IU vitamin D3boosted vitamin D status but did not influence growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.KEY MESSAGES What is already known on this topic? <jats:list list-type="bullet">Observational studies have reported independent associations between vitamin D deficiency in childhood and slower linear growth, reduced lean mass, obesity and precocious puberty.A phase 2 clinical trial conducted in Mongolia reported that a 6-month course of vitamin D supplementation increased height gain in 113 vitamin D deficient schoolchildren aged 12-15 years; however, these results were not confirmed by a recent phase 3 trial conducted in the same setting.RCTs to determine effects of vitamin D supplementation on growth and development in schoolchildren have not been conducted in other settings.What this study adds <jats:list list-type="bullet">This placebo-controlled phase 3 clinical trial, conducted in 1682 Black African schoolchildren in Cape Town, South Africa, showed that a 3-year course of weekly vitamin D supplementation was effective in elevating circulating 25-hydroxyvitamin D concentrations.However, this was not associated with any effect on linear growth, body composition, pubertal development or spirometric lung volumes.How this study might affect research, practice or policy <jats:list list-type="bullet">Our findings do not support use of vitamin D supplementation as an intervention to influence child growth, body composition, pubertal development or spirometric lung volumes..
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Preprint| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
bioRxiv.org - (2024) vom: 23. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Middelkoop, Keren [VerfasserIn] |
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| doi: |
10.1101/2023.11.29.23299226 |
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| PPN (Katalog-ID): |
XBI041717643 |
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| 245 | 1 | 0 | |a Influence of vitamin D supplementation on growth, body composition, pubertal development and spirometry in South African schoolchildren: a randomised controlled trial (ViDiKids) |
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| 520 | |a ABSTRACT Objective To determine whether weekly oral vitamin D supplementation influences growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.Design Phase 3 double-blind randomised placebo-controlled trial (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">clinicaltrials.gov</jats:ext-link>registration no.<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT02880982">NCT02880982</jats:ext-link>).Setting Socio-economically disadvantaged peri-urban district of Cape Town, South AfricaParticipants 1682 children of Black African ancestry attending government primary schools and aged 6-11 years at baseline.Interventions Oral vitamin D3(10,000 IU/week) vs. placebo for 3 yearsMain outcome measures height-for-age and body mass index-for-age, measured in all participants); Tanner scores for pubertal development, spirometric lung volumes and body composition, measured in a subset of 450 children who additionally took part in a nested sub-study.Results Mean serum 25-hydroxyvitamin D3concentration at 3-year follow-up was higher among children randomised to receive vitamin D vs. placebo (104.3 vs. 64.7 nmol/L, respectively; mean difference [MD] 39.7 nmol/L, 95% CI 37.6 to 41.9 nmol/L). No statistically significant differences in height-for-age z-score (adjusted MD [aMD] −0.08, 95% CI −0.19 to 0.03) or body mass index-for-age z-score (aMD −0.04, 95% CI −0.16 to 0.07) were seen between vitamin D vs. placebo groups at follow-up. Among sub-study participants, allocation to vitamin D vs. placebo did not influence pubertal development scores, % predicted forced expiratory volume in 1 second (FEV1), % predicted forced vital capacity (FVC), % predicted FEV1/FVC, fat mass or fat-free mass.Conclusions Weekly oral administration of 10,000 IU vitamin D3boosted vitamin D status but did not influence growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.KEY MESSAGES What is already known on this topic? <jats:list list-type="bullet">Observational studies have reported independent associations between vitamin D deficiency in childhood and slower linear growth, reduced lean mass, obesity and precocious puberty.A phase 2 clinical trial conducted in Mongolia reported that a 6-month course of vitamin D supplementation increased height gain in 113 vitamin D deficient schoolchildren aged 12-15 years; however, these results were not confirmed by a recent phase 3 trial conducted in the same setting.RCTs to determine effects of vitamin D supplementation on growth and development in schoolchildren have not been conducted in other settings.What this study adds <jats:list list-type="bullet">This placebo-controlled phase 3 clinical trial, conducted in 1682 Black African schoolchildren in Cape Town, South Africa, showed that a 3-year course of weekly vitamin D supplementation was effective in elevating circulating 25-hydroxyvitamin D concentrations.However, this was not associated with any effect on linear growth, body composition, pubertal development or spirometric lung volumes.How this study might affect research, practice or policy <jats:list list-type="bullet">Our findings do not support use of vitamin D supplementation as an intervention to influence child growth, body composition, pubertal development or spirometric lung volumes. | ||
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| 700 | 1 | |a Walker, Neil |e verfasserin |4 aut | |
| 700 | 1 | |a Jolliffe, David A |e verfasserin |4 aut | |
| 700 | 1 | |a Mendham, Amy E |e verfasserin |4 aut | |
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| 700 | 1 | |a Momand, Waheedullah |e verfasserin |4 aut | |
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| 700 | 1 | |a Wilkinson, Robert J |e verfasserin |4 aut | |
| 700 | 1 | |a Bekker, Linda-Gail |e verfasserin |4 aut | |
| 700 | 1 | |a Martineau, Adrian R |e verfasserin |4 aut | |
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