Half of infants had less than 20 ng of Vitamin D with 800 IU (need more) – RCT

800 IU versus 400 IU per day of vitamin D 3 in term breastfed infants: a randomized controlled trial from an LMIC

Eur J Pediatr. 2022 Sep;181(9):3473-3482. doi: 10.1007/s00431-022-04533-5

Bharti Yadav # 1 , Neeraj Gupta # 2 , Rohit Sasidharan 1 , Sivam Thanigainathan 1 , Purvi Purohit 3 , Kuldeep Singh 4 , Praveen Sharma 3 , Arun Singh 1

This open-label, block-randomized controlled trial compared the effect of 800 IU/day and 400 IU/day of oral vitamin D3 supplementation in reducing vitamin D insufficiency (VDI) among healthy-term breastfed infants at 14 weeks of postnatal age. All eligible infants were randomized to receive either 800 or 400 IU/day of oral vitamin D3 (starting within the first week until 14 weeks). The primary outcome was the proportion of infants with VDI (25-OH-D < 20 ng/ml) at 14 weeks. Secondary outcomes were vitamin D deficiency (VDD, < 12 ng/ml), severe VDD (< 5 ng/ml), anthropometry, biochemical or clinical rickets, and any adverse events related to vitamin D toxicity (VDT). Among 102 enrolled infants, the distribution of baseline variables (including cord 25-OH-D levels; 13.0 versus 14.2 ng/ml) was similar in both groups.

On intention-to-treat analysis, the proportions of infants with VDI at 14 weeks were significantly lower in the 800 IU group compared to those in the 400 IU group [24% versus 55%; RR 0.44; 95% CI: 0.25-0.76].

The proportions of infants with elevated parathormone (6% versus 26.5%; p = 0.012) and severe VDD (0% versus 12.2%; p = 0.033) were significantly lower in the 800 IU group. Clinical rickets developed in three (6.2%) infants in the 400 IU group. No infant developed VDT.

Conclusions: Daily oral supplementation with 800 IU of vitamin D3 resulted in an almost 50% reduction in the proportion of infants with VDI and prevented the occurrence of severe VDD at 14 weeks of age compared to 400 IU with no evidence of vitamin D toxicity. Trial Registration: Clinical Trial Registry of India (CTRI/2019/02/017374).

See also VitaminDWiki

• Third study found that Infants needed 1600 IU of vitamin D – JAMA RCT May 2013

• Vitamin D for infants – 100,000 IU monthly is better than 400 IU daily – RCT Oct 2020

  2,000 IU for infants

• Children need 2000 IU of Vitamin D (India) - RCT May 2019 to get 97.5% to 20 ng

• 2,000 IU of vitamin D reduced schizophrenia chance by 77 percent (male infants) - 2004

  Breastfeeding

• Breastfed Infants need more than an daily average of 800 IU of Vitamin D – RCT June 2022

• Vitamin D required for breastfed infants – daily or monthly, infant or mother – Jan 2017 unless mother was getting >6,400 IU

• Breastfed infants 6 times more likely to deficient in Vitamin D and Iron – Aug 2015

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