A randomized clinical trial comparing 3 different replacement regimens of vitamin D in clinically asymptomatic pediatrics and adolescents with vitamin D insufficiency
Italian Journal of Pediatrics, DOI: 10.1186/s13052-016-0314-z Published: 7 December 2016
Iman M. TalaatEmail author, Naglaa M. Kamal, Hamed A. Alghamdi, Abdulla A. Alharthi and Mohamed A. Alshahrani
Ages ranged from 2 to 18 years
Amazing that they did not vary the dose size with weight, obesity, etc.
See also VitaminDWiki
- 4,000 IU of Vitamin D daily is safe, but takes a year to plateau (Best-D) – RCT Dec 2016 adults
- 5,000 IU daily or 50,000 IU Vitamin D weekly repleted many dark skinned adolescents – RCT Dec 2015
- Vitamin D deficiency 4X more likely in Italian teens if: dark skin, winter, obese, little sun, or use sunscreen – June 2014
- Italian youth vitamin D deficiency increased likelihood: 27X if winter, 5X if obese, etc. – Aug 2013
- Note: study on this page was in Italy
- Rapid Normalization of Vitamin D in Critically Ill Children (10,000 IU per kg) – clinical trial
- Overview Loading of vitamin D restore vitamin D level in weeks, rather than a year
Infant-Child category 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 doubles the amount of vitamin D permitted in milk – 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
Download the PDF from VitaminDWiki
Background
Pediatric and Adolescent populations both have special needs for vitamin D especially for growing bone. Inadequate vitamin D is defined as 25 (OH) D(25hydroxy vitamin D) < 30 ng/ml.
Methods
We conducted a randomized, controlled clinical trial from July 2014 over 1 year, aiming to assess the changes in 25 (OH) D and biochemical outcome on calcium and PTH(parathyroid hormone) using 3 different regimens of vitamin D replacement. Initial and 4 month 25 (OH) D, calcium, PTH and 12 month 25 (OH) D levels were assayed. Participants divided into 3 groups:
- 1) given 400 IU daily,
- 2) given 45000 IU weekly for 2 months then 400 IU daily,
- 3) given 2000 IU daily for 3 months then 1000 IU daily.
Results
The results showed significant difference between the 3 groups as regards 25 (OH) D at 4 and 12 months (P < 0.001). Regimens used in group 2 and 3 caused increase in 25 (OH) D after 4 month (median increase is 225% and 200% respectively). 25 (OH) D dropped in group 1 and 2 (median decrease is 42 and 53% respectively) but continued to increase in group 3 (median change is 6%). In group 2 serum calcium median change was 1.2% with few cases of hypercalcuria. 94.9, 76.1 and 7.7 are the percent of vitamin D deficient participants in groups 1, 2 and 3 respectively after 12 months follow up.
Conclusion
We advise as a replacement for vitamin D insufficiency, low loading dose with high maintaince dose rather than the opposite to achieve steady increase in serum 25 (OH) D with no hypercalcemic side effects.
From Conclusions in PDF
Till now, no standard regimen is available for treatment of
vitamin D insufficiency. We recommend low loading dose
of vitamin D around 100.000 to 200.000 IU with high
maintaince dose of 1000 IU as a way of replacement rather
than initial high dose and a low maintaince dose as the
later can cause temporary rise of 25 (OH) D and hypercalcemic
side effects.