1200 IU vs 400 IU of vitamin D did not improve bone health or immunity of children who were sufficient – RCT

Created July 2018

Effect of Higher vs Standard Dosage of Vitamin D3 Supplementation on Bone Strength and Infection in Healthy Infants -A Randomized Clinical Trial

JAMA Pediatr. 2018;172(7):646-654. doi:10.1001/jamapediatrics.2018.0602

Jenni Rosendahl, MD1; Saara Valkama, MD1; Elisa Holmlund-Suila, MD, PhD1; et al Maria Enlund-Cerullo, MD, MSc1,2; Helena Hauta-alus, MSc1; Otto Helve, MD, PhD1,3; Timo Hytinantti, MD, PhD1; Esko Levälahti, MSc3; Eero Kajantie, MD, PhD1,3,4; Heli Viljakainen, PhD2; Outi Mäkitie, MD, PhD1,2,5; Sture Andersson, MD, PhD1

* 96% were sufficient (> 20 ng) at the start of the trial, so not much expected * Did not seem to include children who need more vitamin D * Obese, premies, dark skinned, breastfed, unhealthy, etc. --- 1. See also VitaminDWiki * * Infant-Child category listing has items along with related searches** * African-American infants had more skin infections at 6 months – Jan 2018 * Vitamin D needed to get children to just 20 ng in winter 800 IU white skin, 1100 IU dark (Sweden) – RCT June 2017 * 83 percent of children had less than 20 ng of vitamin D – 15 ng avg for hispanic – Aug 2012 * vs in this study 97% of children had > 20 ng * Preemies need 1,000 IU of vitamin D – RCT Sept 2017 Infant-Child category starts with {include} {include}

Key Points

  • Question Does a higher dose (1200 IU) of supplemental vitamin D3 administered to healthy infants increase bone strength or decrease incidence of infections compared with the standard dose (400 IU)?

  • Findings This randomized clinical trial of 975 infants found no difference in bone strength or incidence of infections between intervention groups at 24 months of age.

  • Meaning In healthy infants, daily supplementation with 1200 IU of vitamin D3 provides no additional benefits compared with supplementation with 400 IU for bone strength or incidence of infections in early childhood.

Importance Although guidelines for vitamin D supplementation in infants have been widely implemented, they are mostly based on studies focusing on prevention of rickets. The optimal dose for bone strength and infection prevention in healthy infants remains unclear.

Objective To determine whether daily supplementation with 1200 IU of vitamin D3 increases bone strength or decreases incidence of infections in the first 2 years of life compared with a dosage of 400 IU/d.

Design, Setting, and Participants A randomized clinical trial involving a random sample of 975 healthy term infants at a maternity hospital in Helsinki, Finland. Study recruitment occurred between January 14, 2013, and June 9, 2014, and the last follow-up was May 30, 2016. Data analysis was by the intention-to-treat principle.

Interventions Randomization of 489 infants to daily oral vitamin D3 supplementation of 400 IU and 486 infants to 1200 IU from age 2 weeks to 24 months.

Main Outcomes and Measures Primary outcomes were bone strength and incidence of parent-reported infections at 24 months.

Results Of the 975 infants who were randomized, 485 (49.7%) were girls and all were of Northern European ethnicity. Eight hundred twenty-three (84.4%) completed the 24-month follow-up. We found no differences between groups in bone strength measures, including bone mineral content (mean difference, 0.4 mg/mm; 95% CI, −0.8 to 1.6), mineral density (mean difference, 2.9 mg/cm3; 95% CI, −8.3 to 14.2), cross-sectional area (mean difference, –0.9 mm2; 95% CI, −5.0 to 3.2), or polar moment of inertia (mean difference, –66.0 mm4, 95% CI, −274.3 to 142.3). Incidence rates of parent-reported infections did not differ between groups (incidence rate ratio, 1.00; 95% CI, 0.93-1.06).

At birth, 914 of 955 infants (95.7%) were vitamin D sufficient (ie, 25-hydroxyvitamin D [25(OH)D] concentration ≥20.03 ng/mL). At 24 months, mean 25(OH)D concentration was higher in the 1200-IU group than in the 400-IU group (mean difference, 12.50 ng/mL; 95% CI, 11.22-13.78).

Conclusions and Relevance A vitamin D3 supplemental dose of up to 1200 IU in infants did not lead to increased bone strength or to decreased infection incidence. Daily supplementation with 400 IU vitamin D3 seems adequate in maintaining vitamin D sufficiency in children younger than 2 years.

Trial Registration ClinicalTrials.gov Identifier: NCT01723852

Tags: Infant-Child Intervention