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

Funding Source

National Institutes of Health

Grant Number

KL2TR001071, TL1TR001072, UL1TR001073


Department of Chemistry

Document Type


Publication Date



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.


DOI: 10.1016/j.jpeds.2015.11.025

PubMed ID: 26707619

Funding Text

Funded by the Michael I. Cohen, MD Fund for Adolescent Medicine, Children''s Hospital at Montefiore, Bronx, NY (for participant incentives); Bio-tech Pharmacal, Inc, Fayetteville, AK (donated the vitamin D products); the National Center for Advancing Translational Sciences (UL1 TR001073, TL1 TR001072, KL2 TR001071 [to H.T. and H.C.]). The authors declare no conflicts of interest.