Treatment Study of Vitamin D Deficiency in Adolescents
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

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] 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.
    

Detailed description: 
      Vitamin D is an essential nutrient and pro-hormone that has garnered widespread attention
      over the past decade for both its known and theorized health benefits. Patients, clinicians
      and researchers have all been alerted to the increasing prevalence of vitamin D deficiency
      (defined as level of 25(OH)D <20 ng/mL) and the significance of the extra-skeletal health
      effects of vitamin D. Aside from the skeletal impacts of Vitamin D, there has been recent
      evidence about potential health benefits of vitamin D related to the multiple extra-skeletal
      roles of this hormone. In fact, vitamin D receptors are found in many organs including brain,
      heart, skin, small intestine, gonads, prostate and breast as well in almost all nucleated
      cells including osteoblasts, activated T and B-lymphocytes, and B islet cells. Studies in
      children and adolescents as well as in adults show associations of vitamin D deficiency with
      cardiovascular risk factors, musculoskeletal health, asthma, and autoimmune diseases.

      While Vitamin D deficiency is quite prevalent, adolescents who are obese or who are darker
      skinned are consistently shown to have higher rates of vitamin D deficiency than lean and
      lighter skinned adolescents. Treatment of vitamin D deficiency and maintenance of sufficient
      levels in adolescents are largely under-studied leaving patients and clinicians without clear
      evidence-based guidelines to follow.

      The goal of this study is to compare the efficacy of different treatment regimens for vitamin
      D deficiency in our population of predominantly minority adolescents and to examine the
      effect of correction of vitamin D deficiency on selected extra-skeletal targets of vitamin D
      action including musculoskeletal, cardiometabolic, and immune function.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescents; minority