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Phase 4 Completed N=183 Randomized Treatment

Treatment Study of Vitamin D Deficiency in Adolescents

Source: ClinicalTrials.gov NCT01784029 ↗
Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: 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
◆ Published Evidence
Established
24citations · ~2 / year
Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial.
The Journal of pediatrics · 2016 · Open access · Likely link

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.

Linked Publications

  • Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial.
    The Journal of pediatrics · 2016 · 24 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01784029) and the linked publication. 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. Informational only — not medical advice.

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