Treatment Study of Vitamin D Deficiency in Adolescents

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01784029

12-09-345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 patients

Sex: All

Ages: 13 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 13-20

Exclusion criteria

• currently receiving treatment for hypovitaminosis D
• hepatic or renal disease
• metabolic rickets
• inability to complete the questionnaire

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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183 participants in 3 patient groups

Low Dose

Experimental group

Description:

VItamin D3 1,000 IU 1 x day, 8 weeks

Treatment:

Drug: Vitamin D3

Weekly High Dose

Experimental group

Description:

Vitamin D3 50,000 IU 1x week, 8 weeks

Treatment:

Drug: Vitamin D3

Daily High Dose

Experimental group

Description:

Vitamin D3 5,000 IU 1x day, 8 weeks

Treatment:

Drug: Vitamin D3