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

VitaminDWiki
  • 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.

See also VitaminDWiki

Infant-Child category starts with

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

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.
    1000 IU per 25 lbs.jpg
    More than 100 IU/kg is probably better

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, oil
One capsule of 50,000 Bio-Tech Pharmacal Vitamin D could be stirred into monthly formula
   this would result in ~1,600 IUs per day for infant, and higher dose with weight/age/formula consumption


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

Created by admin. Last Modification: Tuesday July 3, 2018 01:00:21 GMT-0000 by admin. (Version 3)
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