Dataset Information

Correction of Low Neonatal Vitamin D Status Using 1000 IU/d of Vitamin D Improved Body Composition (Lean Mass and Fat Mass) Compared to Using the Standard of Care by 6 Months of Age (P11-094-19)

ABSTRACT: 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.

SUBMITTER: Razaghi M

PROVIDER: S-EPMC6574261 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Project description: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.

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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