5,000 IU daily or 50,000 IU Vitamin D weekly repleted many dark skinned adolescents – RCT

Created December 2015

Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial

Journal of Pediatrics – online first

Hina J. Talib, MDcorrespondenceemail, Tulasi Ponnapakkam, PhD, Robert Gensure, MD, PhD, Hillel W. Cohen, DrPH, MPH, Susan M. Coupey, MD

A short 8 week trial 1. || |30 ng 50,000 IU weekly| 72% 5,000 IU daily |56% 1,000 IU daily|2%|| Much better if non-obese See also VitaminDWiki * African-Americans need only 20 ng of vitamin, not 30 ng, based on iPTH – Sept 2012 * Extra 4,000 IU daily raised the vitamin D levels of blacks to that of whites – July 2012 * Overview Dark Skin and Vitamin D * Inflammation in African Americans not reduced with 3 months of 4000 IU of vitamin D – RCT Dec 2013 * Many healthy African Americans got above 33 ng with 4,000 IU of vitamin D – RCT March 2014 * That 12 week trial was more successful than the 8 week trial on this page * Note - vitamin D levels are often still rising even at 12 weeks * Response times are 12-20 weeks Intervention AND Skin - Dark in VitaminDWiki {category}

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Objectives

To compare 3 different treatment regimens for vitamin D deficiency in minority adolescents and to explore factors that impact treatment efficacy.

Study design

We conducted an 8-week, prospective, open-label, randomized clinical trial in an urban, academic, children's hospital.

A total of 183 vitamin D-deficient adolescents,
mean 25-hydroxyvitamin D or 25(OH)D 13.7 ± 3.9 ng/mL;
mean age 16.6 ± 2.2 years,

were randomized into 3 vitamin D3 (cholecalciferol) treatment arms: 50 000 IU/wk; 5000 IU/d; and 1000 IU/d. Serum 25(OH)D and vitamin D binding protein (VDBP) levels were measured pre-and posttreatment; 122 (67%) participants completed posttreatment measures. Complete-case and multiple-imputation, intention-to-treat analyses were performed.

Results

Mean change in 25(OH)D level posttreatment was significantly different among the 3 arms, 24.9 ± 15.1 vs 21.0 ± 15.2 vs 6.2 ± 6.5 ng/mL, for 50 000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001. Both high-dose treatments were effective in increasing the 25(OH)D level out of deficiency range (≥20 ng/mL) in more than 80% of participants, and 60% remained deficient after low-dose treatment. Only 72%, 56%, and 2% achieved vitamin D sufficiency (>30 ng/mL) with 50 000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001.

Obese participants had substantially less mean change in 25(OH)D level after treatment than normal-weight participants, 13.7 ± 10.7 vs 21.9 ± 16.9 ng/mL, P < .001.

Mean baseline VDBP level was almost twice as high in Hispanic compared with black participants (P < .001) and did not alter treatment response or change with treatment.

Conclusions

Adult-sized adolescents require 8 weeks of high-dose cholecalciferol, at least 5000 IU/d, to correct deficiency. Obese adolescents have poorer response to treatment and may need higher doses than nonobese youth. Hispanic and black adolescents have different VDBP levels but similar treatment responses.

Trial registration: ClinicalTrials.gov: NCT01784029.

Tags: Darker Skin Intervention Intervention - non daily Obesity Vit D Binding Protein Youth