Hina J Talib1, Tulasi Ponnapakkam2, Robert Gensure2, Hillel W Cohen3, Susan M Coupey4. 1. Division of Adolescent Medicine, Children's Hospital at Montefiore/Albert Einstein College of Medicine, Bronx, NY. Electronic address: htalib@montefiore.org. 2. Division of Pediatric Endocrinology, Children's Hospital at Montefiore/Albert Einstein College of Medicine, Bronx, NY. 3. Albert Einstein College of Medicine, Bronx, NY. 4. Division of Adolescent Medicine, Children's Hospital at Montefiore/Albert Einstein College of Medicine, Bronx, NY.
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 Dbinding 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.
RCT Entities:
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. Obeseparticipants 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.
Authors: Nazia Raja-Khan; Julie Shah; Christy M Stetter; Mary E J Lott; Allen R Kunselman; William C Dodson; Richard S Legro Journal: Fertil Steril Date: 2014-03-14 Impact factor: 7.329
Authors: Kumaravel Rajakumar; Charity G Moore; Jonathan Yabes; Flora Olabopo; Mary Ann Haralam; Diane Comer; Jaimee Bogusz; Anita Nucci; Susan Sereika; Jacqueline Dunbar-Jacob; Michael F Holick; Susan L Greenspan Journal: J Clin Endocrinol Metab Date: 2015-06-19 Impact factor: 5.958
Authors: Thomas O Carpenter; Jane H Zhang; Esteban Parra; Bruce K Ellis; Christine Simpson; William M Lee; Jody Balko; Lei Fu; Betty Y-L Wong; David E C Cole Journal: J Bone Miner Res Date: 2013-01 Impact factor: 6.741
Authors: Michael F Holick; Rachael M Biancuzzo; Tai C Chen; Ellen K Klein; Azzie Young; Douglass Bibuld; Richard Reitz; Wael Salameh; Allen Ameri; Andrew D Tannenbaum Journal: J Clin Endocrinol Metab Date: 2007-12-18 Impact factor: 5.958
Authors: Giuseppe Saggese; Francesco Vierucci; Flavia Prodam; Fabio Cardinale; Irene Cetin; Elena Chiappini; Gian Luigi De' Angelis; Maddalena Massari; Emanuele Miraglia Del Giudice; Michele Miraglia Del Giudice; Diego Peroni; Luigi Terracciano; Rino Agostiniani; Domenico Careddu; Daniele Giovanni Ghiglioni; Gianni Bona; Giuseppe Di Mauro; Giovanni Corsello Journal: Ital J Pediatr Date: 2018-05-08 Impact factor: 2.638
Authors: Daniel L Dickerson; Jennifer Parker; Carrie L Johnson; Ryan A Brown; Elizabeth J D'Amico Journal: Clin Trials Date: 2020-11-24 Impact factor: 2.486