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

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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 Jun 21. 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).
What is Known: • Breastfeeding is the ideal source of nutrition for healthy-term breastfed infants; however, vitamin D content of breastmilk is suboptimal. • AAP recommends daily oral supplementation of 400 IU of vitamin D to all healthy-term breastfed infants; however, trials from high-income countries support insufficiency of this dose in maintaining serum 25-OH-D levels >20 ng/ml with no such information from low-middle-income countries. What is New: • 800 IU/day of oral vitamin D3 supplementation among term breastfed infants significantly reduces vitamin D insufficiency at 14 weeks' age as compared to the recommended dose of 400 IU/day. • This higher supplemental dose is safe with no evidence of vitamin D toxicity.

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RCT Results Summary

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Vitamin D Life - Infant-Child category has 702 items and starts with__

• No consensus on MINIMUM International Units (IU) for healthy infant of normal weight
• 400 IU Vitamin D is no longer enough
  Was OK in the past century, but D levels have been dropping for a great many reasons.
  FDA doubled the vitamin D level in milk in July 2016
• No consensus: range is 600 to 1600 IU – based on many randomized controlled trials
• Review of 400 IU to 2000 IU daily and higher if non-daily
• Fewer pre-infants were vitamin D deficient when they got 800 IU – RCT Feb 2014
• 1600 IU was the conclusion of three JAMA studies
     1000 IU recommended in France and Finland – 2013 - appears to be a good level
• 5X less mite allergy after add vitamin D
• Child bone fractures with low vitamin D were 55X more likely to need surgery
• 75 % of SIDS had low vitamin D
• Children stayed in ICU 3.5 days longer if low vitamin D – Dec 2015
• 5 out of 6 children who died in pediatric critical care unit had low vitamin D – May 2014
• Infants have gotten free 400 IU of vitamin D in Turkey since 2005, More for longer would be even better – Feb 2022
• Preemies should have vitamin D supplements – reaching an agreement – April 2021
• Vitamin D loading dose was as effective as daily dosing (rickets in this case) – RCT July 2021

Having a good level of vitamin D cuts in half the amount of:

• Asthma, Chronic illness, Doctor visits, Allergies, infection
  Respiratory Tract Infection, Growing pains, Bed wetting

Need even more IUs of vitamin D to get a good level if;

• Have little vitamin D: premie, twin, mother did not get much sun access
• Get little vitamin D: dark skin, little access to sun
• Vitamin D is consumed faster than normal due to sickness
• Older (need at least 100 IU/kilogram, far more if obese)
• Not get any vitamin D from formula (breast fed) or (fortified) milk
  Note – formula does not even provide 400 IU of vitamin D daily

Infants-Children need Vitamin D

• Sun is great – well known for 1,000’s of years.
  US govt (1934) even said infants should be out in the sun
• One country recommended 2,000 IU daily for decades – with no known problems
• As with adults, infants and children can have loading doses and rarely need tests
• Daily dose appears to be best, but monthly seems OK
• Vitamin D is typically given to infants in the form of drops
     big difference in taste between brands
     can also use water-soluable form of vitamin D in milk, food, juice,
• Infants have evolved to get a big boost of vitamin D immediately after birth
  Colostrum has 3X more vitamin D than breast milk - provided the mother has any vitamin D to spare
• 100 IU per kg of infant July 2011, Poland etc.
  
  More than 100 IU/kg is probably better

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Did you know that:

Getting Vitamin D into infants
Many infants reject vitamin D drops, even when put on nipple
I speculate that the rejection is due to one or more of: additives, taste, and oils.
Infants have a hard time digesting oils, 1999  1997   and palm oils W.A. Price 1 2 3
Coconut oil, such as in D-Drops, is digested by infants. 1,   2   3
Bio-Tech Pharmacal Vitamin D has NO additves, taste, nor oil
One capsule of 50,000 Bio-Tech Pharmacal Vitamin D could be stirred into monthly formula or given once a month
   this would result in ~1,600 IUs per day for infant, and higher dose with weight/age/formula consumption

• 702 items in the category Infant/Child See also
• 34 pages in Vitamin D Life had BREASTFE*in title as of Jan 2022
• "BIRTH DEFECTS" 172 items as of July 2016
• Stunting OR “low birth weight” OR LBW OR preemie OR preemies OR preterm 1940 items as of Oct 2018
• 96 Vitamin D Life pages contained PRETERM or PREEMIE in title as of Aug 2021
• "SUDDEN INFANT DEATH" OR SIDS 214 items as of Dec 2020
• Overview of Rickets and Vitamin D
• Youth category listing has 161 items along with related searches

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Related

• Preemies need 1,000 IU of vitamin D – RCT Sept 2017
• Vitamin D for infants – 100,000 IU monthly is better than 400 IU daily – RCT Oct 2020
• 2,000 IU of vitamin D reduced schizophrenia chance by 77 percent (male infants) - 2004
• Third study found that Infants needed 1600 IU of vitamin D – JAMA RCT May 2013