Dataset Information

Insufficient Vitamin D Status at Birth Is Corrected by Vitamin D Supplementation (1000 IU/Day) With Increases in Lean Mass Evident at 12 Months of Age in Healthy Term Infants

ABSTRACT: Abstract

Objectives

The primary objective was to test whether rapid correction of insufficient vitamin D status initiated in the neonatal period improves whole-body lean mass across infancy.

Methods

This was a double-blinded, parallel-group, randomized controlled trial (NCT02563015). Healthy term breastfed infants of appropriate weight for gestational age (AGA) were recruited from Montreal (March 2016–2019). Capillary blood was collected (24–36 h) for serum 25-hydroxyvitamin D [25(OH)D] measurement (Liaison, Diasorin Inc.). Infants with serum 25(OH)D < 50 nmol/L were randomized to receive 400 (group 1, n = 49) or 1000 IU/d (group 2, n = 49) until 12 mo of age. Those with 25(OH)D ≥ 50 nmol/L were recruited to form a reference group, receiving 400 IU/d (group 3, n = 41). Anthropometry, body composition (dual-energy x-ray absorptiometry), and 25(OH)D concentrations were assessed at 1, 3, 6, and 12 mo. Differences between trial and reference groups were tested using mixed model repeated measures ANOVA adjusting for maternal pregnancy weight gain, infant sex, skin color, actual age at assessment, and breastfeeding status. Data are mean ± SD.

Results

Infants (81 males, 58 females) were 39.6 ± 1.0 wk GA and 3388 ± 372 g at birth. By design, infants in group 1 and 2 had lower serum 25(OH)D concentrations at birth compared to group 3 (31.1 ± 9.3, 34.4 ± 12.0 vs. 68.0 ± 13.2 nmol/L, respectively, P < 0.0001). On average, both trial groups achieved and maintained vitamin D sufficiency (25(OH)D ≥ 50 nmol/L) from 3 to 12 mo. Lean mass was not different among groups at baseline, but at 12 mo was higher in group 2 compared to group 1 (7012.5 ± 904.6 vs. 6690.4 ± 1121.7 g, P = 0.0075; 4.8% difference), and not different from the reference group (7012.5 ± 904.6 vs. 6715.1 ± 784.6 g, P = 0.2882). Weight, length, and whole-body fat mass were not different among groups at any time-point.

Conclusions

Vitamin D supplementation (400 and 1000 IU/d) corrects insufficient stores, whereas the higher dosage of 1000 IU/d, modestly increases lean mass of otherwise healthy AGA term born infants by 12 mo of age without altering weight or length. These data concur with observations in weanling rats where increased vitamin D intakes elevated lean mass. The long-term benefits require further research.

Funding Sources

Funded by Canadian Institutes of Health Research.

SUBMITTER: Razaghi M

PROVIDER: S-EPMC8181688 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIntrauterine exposure to maternal vitamin D status <50 nmol/L of serum 25-hydroxyvitamin D [25(OH)D] may adversely affect infant body composition. Whether postnatal interventions can reprogram for a leaner body phenotype is unknown.ObjectivesThe primary objective was to test whether 1000 IU/d of supplemental vitamin D (compared with 400 IU/d) improves lean mass in infants born with serum 25(OH)D <50 nmol/L.MethodsHealthy, term, breastfed infants (Montréal, Canada, March 2016-2019) were assessed for serum 25(OH)D (immunoassay) 24-36 h postpartum. Infants with serum 25(OH)D <50nmol/L at 24-36 h were eligible for the trial and randomly assigned at baseline (1 mo postpartum) to 400 (29 males, 20 females) or 1000 IU/d (29 males, 20 females) of vitamin D until 12 mo. Infants (23 males, 18 females) with 25(OH)D ≥50 nmol/L (sufficient) formed a nonrandomized reference group provided 400 IU/d. Anthropometry, body composition (DXA), and serum 25(OH)D concentrations were measured at 1, 3, 6, and 12 mo.ResultsAt baseline, mean ± SD serum 25(OH)D concentrations in infants allocated to the 400 and 1000 IU/d vitamin D groups were 45.8 ± 14.1 and 47.6 ± 13.4, respectively; for the reference group it was 69.2 ± 16.4 nmol/L. Serum 25(OH)D concentration increased on average to ≥50 nmol/L in the trial groups at 3-12 mo. Lean mass varied differently between groups over time; at 12 mo it was higher in the 1000 IU/d vitamin D group than in the 400 IU/d group (mean ± SD: 7013 ± 904.6 compared with 6690.4 ± 1121.7 g, P = 0.0428), but not the reference group (mean ± SD: 6715.1 ± 784.6 g, P = 0.19). Whole-body fat mass was not different between the groups over time.ConclusionsVitamin D supplementation (400 or 1000 IU/d) during infancy readily corrects vitamin D status, whereas 1000 IU/d modestly increases lean mass by 12 mo. The long-term implications require further research. This trial was registered at clinicaltrials.gov as NCT02563015.

Project description:Abstract Objectives Vitamin D status is positively associated with lean mass phenotype in healthy infants born with sufficient vitamin D stores. The objective is to test whether rapid correction of low neonatal vitamin D status improves body composition (lean mass and fat mass) at 6 mo of age. Methods In a double-blinded randomized parallel group controlled trial (NCT02563015), healthy term neonates of appropriate weight for gestational age were recruited from Montreal. Capillary blood samples were collected 24–36 h post natally for measurement of serum 25-hydroxyvitamin D [25(OH)D] (Liaison, Diasorin Inc.). Infants with serum 25(OH)D < 50 nmol/L (n = 87) were randomized to receive 400 or 1000 IU/d until 6 mo of age. Those with 25(OH)D ≥ 50 nmol/L (n = 31) were recruited as a reference group, and received 400 IU/d. Anthropometry, lean mass and fat mass (dual-energy x-ray absorptiometry) were measured at baseline, 3 and 6 mo. Skin color was measured using a spectrophotometer. Differences between treatments and reference groups were tested using mixed model and repeated measures ANOVA accounting for the effects of sex, season of birth, skin color and gestational age (GA). Results Neonates (67 males, 51 females) were 39.6 ± 1wk GA and 3387 ± 371 g at birth. There were no differences between groups in lean mass or fat mass at baseline; nor in weight or length at any time-point. Combined treatment groups, had lower serum 25(OH)D concentrations at birth compared to the reference group (33 ± 11 vs. 69 ± 13 nmol/L, P < 0.0001). However, at 6 mo of age, serum 25(OH)D concentration was higher in the group receiving 1000 IU/d (n = 34), in comparison to the group receiving 400 IU/d (n = 29), and the reference (n = 19) group (125.0 ± 34.0, 82.2 ± 21.5 vs. reference 85.4 ± 32.1 nmol/L, P < 0.0001). Whole body lean mass was significantly different among groups (5071.3 ± 750.0, 4944.1 ± 616.3 and 5166.0 ± 645.4 g, respectively, P = 0.03), with infants in the treatment group provided a 400 IU/d supplement having a lower lean mass by 6 mo of age compared to the 1000 IU/d group. Fat mass was not different among groups following post-hoc testing (2967.0 ± 929.0 and 2962.0 ± 952.0, 2742.0 ± 754.0 g, P = 0.16). Conclusions Higher dosage supplementation of vitamin D rapidly improved vitamin D status and supported a leaner body phenotype in infancy. Funding Sources Canadian Institutes of Health Research.

Project description:BACKGROUND:The appropriate dose of vitamin D supplementation in children is still debated. We calculated that the recommended dose of 600-1000?IU vitamin D3/day is not sufficient to reach a serum 25-hydroxyvitamin D (25-OH-D) level of at least 30?ng/ml (75?nmol/l) in north Italian children >?12?months. The aim of this study was to analyse the effect of seasonal supplementation with 1500?IU (=37.5??g) vitamin D3/day. METHODS:DINOS (D-vitamIN Oral Supplementation) study was a pilot, monocentric, non-random case-control register study. It was conducted in a paediatric primary care setting near Padova (North Italy, 45°N latitude). The data of 203 children (girls:boys 1:1,33) aged 2-15?years, collected between November 2010 and January 2015, were analysed. Active group A (n?=?82) were given 1500?IU vitamin D3/day from November to April; control Group B (n?=?121) received no supplementation. The serum 25-OH-D test was part of a laboratory tests panel and performed using a chemiluminescence immunoassay method. RESULTS:Serum 25-OH-D mean level + standard deviation throughout the period was 32 + 13?ng/ml (80 + 32?nmol/l) in group A vs 22 + 10?ng/ml (55 + 25?nmol/l) in group B. In group A 12% had vitamin D deficiency 25-OH-D?<?20?ng/ml (50?nmol/l) and 1.2% severe vitamin D deficiency 25-OH-D?<?10?ng/ml (25?nmol/l). In group B 46% had vitamin D deficiency and 9% severe deficiency (P?<? 0.001). In group A mean levels were normal or near-normal all the year except in May. Group B reached mean 25-OH-D levels close to 30?ng/ml (75?nmol/l) only in late summer. The active group mean 25-OH-D level was normal in preschoolers and schoolers but not in adolescents. Non-white children had a three-times vitamin D deficiency probability despite supplementation. CONCLUSIONS:Vitamin D supplementation with at least 1500?IU vitamin D3/day from November to April was found appropriate for children in North Italy. A prolongation until May could be useful. Higher doses and/or prolonged periods could be more appropriate especially in adolescents and in non-white children. STUDY REGISTRATION:DINOS gained the approval of Padova Ethics Committee (n. 3960/U16/2016).

Project description:Vitamin D deficiency has been associated with an increased risk of COVID-19 severity. This multi-center randomized clinical trial aims to determine the effects of 5000 IU versus 1000 IU daily oral vitamin D3 supplementation in the recovery of symptoms and other clinical parameters among mild to moderate COVID-19 patients with sub-optimal vitamin D status. A total of 69 reverse transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 positive adults who were hospitalized for mild to moderate COVID-19 disease were allocated to receive once daily for 2 weeks either 5000 IU oral vitamin D3 (n = 36, 21 males; 15 females) or 1000 IU oral vitamin D3 (standard control) (n = 33, 13 males; 20 females). Anthropometrics were measured and blood samples were taken pre- and post-supplementation. Fasting blood glucose, lipids, serum 25(OH)D, and inflammatory markers were measured. COVID-19 symptoms were noted on admission and monitored until full recovery. Vitamin D supplementation for 2 weeks caused a significant increase in serum 25(OH)D levels in the 5000 IU group only (adjusted p = 0.003). Within-group comparisons also showed a significant decrease in BMI and IL-6 levels overtime in both groups (p-values < 0.05) but was not clinically significant in between-group comparisons. Kaplan-Meier survival analysis revealed that the 5000 IU group had a significantly shorter time to recovery (days) than the 1000 IU group in resolving cough, even after adjusting for age, sex, baseline BMI, and D-dimer (6.2 ± 0.8 versus 9.1 ± 0.8; p = 0.039), and ageusia (loss of taste) (11.4 ± 1.0 versus 16.9 ± 1.7; p = 0.035). A 5000 IU daily oral vitamin D3 supplementation for 2 weeks reduces the time to recovery for cough and gustatory sensory loss among patients with sub-optimal vitamin D status and mild to moderate COVID-19 symptoms. The use of 5000 IU vitamin D3 as an adjuvant therapy for COVID-19 patients with suboptimal vitamin D status, even for a short duration, is recommended.

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Project description:IntroductionAlthough vitamin D is widely known as an essential micronutrient during pregnancy, the exact supplementation dose to prevent maternal-fetal outcomes remains a question. This study aims to provide a systematic review and a meta-analysis of data from randomized controlled trial on > 2000 IU/day vitamin D supplementation compared to ⩽ 2000 IU/day; and ⩽ 2000 IU/day compared to placebo, on their effects on the incidence of preeclampsia, gestational diabetes mellitus, preterm birth, and differences on birth weight.MethodsA systematic literature search on PubMed, EBSCO-MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases was carried out to evaluate randomized controlled trial studies on the effects of oral vitamin D > 2000 IU/day versus ⩽ 2000 IU/day; and ⩽ 2000 IU/day versus placebo, on preeclampsia, gestational diabetes mellitus, preterm birth and birth weight. Risk ratio, mean difference, and 95% confidence interval were calculated.ResultsThere were a total of 27 randomized controlled trials selected. Maternal vitamin D supplementation > 2000 IU/day had a positive effect only on gestational diabetes mellitus (seven randomized controlled trials; risk ratio = 0.70, 95% confidence interval: 0.51-0.95, I2 = 0). Vitamin D supplementation ⩽ 2000 IU/day has reduced the risk of preeclampsia (three randomized controlled trials; risk ratio = 0.29, 95% confidence interval: 0.09-0.95, I2 = 0), with no significant difference when compared to > 2000 IU/day (eight randomized controlled trials; risk ratio = 0.80, 95% confidence interval: 0.51-1.24, I2 = 31). No difference in preterm birth risk and birth weight after vitamin D supplementation. The quality of evidence varies from moderate to very low certainty. The risk of preeclampsia and gestational diabetes mellitus after high-dose versus low-dose vitamin D supplementation was the ones with moderate certainty.ConclusionVitamin D supplementation > 2000 IU/day might be important to reduce the risk of gestational diabetes mellitus. Lower dose vitamin D supplementation (⩽ 2000 IU/day) seemed adequate to reduce the risk of preeclampsia, with no significant difference compared to the higher dose.