Title

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

Department of Chemistry

Document Type

Article

Publication Date

3-1-2016

Abstract

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.

Comments

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.

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