Treatment Study of Vitamin D Deficiency in Adolescents
Completed · Phase 4
Conditions studied: Vitamin D Deficiency
In brief
To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly Hispanic and black adolescents with vitamin D deficiency \[25(OH)D level \<20 ng/ml\] by assessing change in 25(OH)D levels before and after 8 weeks of treatment. To compare the effects of vitamin D repletion \[25(OH)D level \>20 ng/mL\] on selected musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black adolescents with vitamin D deficiency \[25(OH)D level \< 20 ng/mL\]. Hypothesis 1: Increase in vitamin D level will be associated with improvement in musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.
Key facts
- Study ID
- NCT01784029
- Run by
- Montefiore Medical Center
- People needed
- 183
- Starts
- 2013-02-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2018-10-16
Who can join
Age: 13 and older, up to 20. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- age 13-20
You may not qualify if…
- currently receiving treatment for hypovitaminosis D
- hepatic or renal disease
- metabolic rickets
- inability to complete the questionnaire
Where it is running
- Children's Hospital at Montefiore Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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