Treatment Study of Vitamin D Deficiency in Adolescents

NCT01784029 | Completed Phase 4 Results DMC

• 1 other identifier: 12-09-345
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

adolescents; minority

Outcome Measures

Primary Outcomes (1)

• Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)

  Baseline to 3 months

Study Arms (3)

Low Dose

EXPERIMENTAL

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

Drug: Vitamin D3

Weekly High Dose

EXPERIMENTAL

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

Drug: Vitamin D3

Daily High Dose

EXPERIMENTAL

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

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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

Also known as: cholecalciferol

Daily High Dose; Low Dose; Weekly High Dose

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 13-20

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Children's Hospital at Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 26707619 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Substantial attrition rate is a limitation of this study.

Results Point of Contact

• Title: Hina Talib
• Organization: Children's Hospital at Montefiore

htalib@montefiore.org

718-920-6781

Study Officials

• Susan M Coupey, MD

  Children's Hospital at Montefiore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Adolescent Medicine

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-09

Locations

US (1)