Treatment Study of Vitamin D Deficiency in Adolescents

NCT ID: NCT01784029

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-07-31

Brief 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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Dose

VItamin D3 1,000 IU

1 x day, 8 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.

Weekly High Dose

Vitamin D3 50,000 IU

1x week, 8 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.

Daily High Dose

Vitamin D3 5,000 IU

1x day, 8 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.

Interventions

Vitamin D3

Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.

Intervention Type: DRUG

Other Intervention Names

cholecalciferol

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Susan Coupey

Chief, Adolescent Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan M Coupey, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital at Montefiore

Locations

Children's Hospital at Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

Talib HJ, Ponnapakkam T, Gensure R, Cohen HW, Coupey SM. Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial. J Pediatr. 2016 Mar;170:266-72.e1. doi: 10.1016/j.jpeds.2015.11.025. Epub 2015 Dec 18.

Reference Type: DERIVED

PMID: 26707619 (View on PubMed)

Other Identifiers

12-09-345

Identifier Type: -

Identifier Source: org_study_id