Phase 4
N=183
Treatment Study of Vitamin D Deficiency in Adolescents
Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01784029 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) — 6.2; 24.9; 21 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vitamin D3 (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) |
6.2; 24.9; 21 | — |
Summary
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] 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.
Eligibility Criteria
Inclusion Criteria
- age 13-20
Exclusion Criteria
- currently receiving treatment for hypovitaminosis D
- hepatic or renal disease
- metabolic rickets
- inability to complete the questionnaire
Data sourced from ClinicalTrials.gov (NCT01784029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.