Treatment Study of Vitamin D Deficiency in Adolescents

• ClinicalTrials.gov Identifier: NCT01784029
• Recruitment Status: Completed
• First Posted: February 5, 2013
• Results First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Susan Coupey, Montefiore Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency	Drug: Vitamin D3	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Standard High-dose Treatment Regimens for Vitamin D Deficiency in Minority Adolescents: Associations of Vitamin D Repletion With Changes in Markers of Musculoskeletal, Cardiometabolic, and Immune Function
• Study Start Date: February 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low Dose; VItamin D3 1,000 IU 1 x day, 8 weeks	Drug: Vitamin D3; Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.; Other Name: cholecalciferol
Experimental: Weekly High Dose; Vitamin D3 50,000 IU 1x week, 8 weeks	Drug: Vitamin D3; Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.; Other Name: cholecalciferol
Experimental: Daily High Dose; Vitamin D3 5,000 IU 1x day, 8 weeks	Drug: Vitamin D3; Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.; Other Name: cholecalciferol

Outcome Measures

Primary Outcome Measures :

1. Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) [ Time Frame: Baseline to 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 20 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, New York

Children's Hospital at Montefiore Medical Center

Bronx, New York, United States, 10467

Sponsors and Collaborators

Montefiore Medical Center

Investigators

• Principal Investigator: Susan M Coupey, MD; Children's Hospital at Montefiore

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Susan Coupey, Chief, Adolescent Medicine, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT01784029
• Other Study ID Numbers: 12-09-345
• First Posted: February 5, 2013
• Results First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Last Verified: September 2018

Keywords provided by Susan Coupey, Montefiore Medical Center:

adolescents; minority

Additional relevant MeSH terms:

Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents