Takes a year to restore children and youths to good levels of vitamin D without loading dose - RCT

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 {include}

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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.