Vitamin D3 Supplementation Pilot Study
Pilot Study of Vitamin D3 Supplementation and Outcomes in Vitamin D Deficient Obese, African American Adolescents
1 other identifier
interventional
39
1 country
1
Brief Summary
The purpose of this research study is to determine whether taking vitamin D, every day, over a 12 week period will improve the vitamin D status, risks for poor heart health, risks for developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers with low vitamin D levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJanuary 23, 2013
January 1, 2013
1.1 years
January 4, 2012
January 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum 25OHD before and after treatment
The analysis will be an intention-to-treat method in which subjects are assumed to obtain all vitamin D supplements from the study and from no other sources, and all subjects are assumed to comply with their assigned dose and daily use. For the main contrasts of interest (5000 IU vs 1000 IU doses as well as serum 25OHD concentrations), we propose a longitudinal mixed effects model with time measurements at 0 and 12 weeks.
12 weeks
Secondary Outcomes (9)
Adiponectin level comparison
12 weeks
Lipid panel comparison
12 weeks
Lipoprotein subclass particles comparison
12 weeks
High-sensitivity C-Reactive Protein (hsCRP) comparison
12 weeks
Insulin level comparison
12 weeks
- +4 more secondary outcomes
Study Arms (2)
Vitamin D3 supplementation of 1000 IU
ACTIVE COMPARATORVitamin D3 supplementation of 5000 IU
ACTIVE COMPARATORInterventions
1000 IU by mouth, once daily for 3 months.
Eligibility Criteria
You may qualify if:
- African American
- Obese \[body mass index (BMI) greater than or equal to 95th percentile for age and sex\]
- Pubertal (Tanner Stage greater than 1)
- OHD less than 20 ng/mL (for treatment phase); if 25OHD is greater than or equal to 20 ng/mL, only baseline data will be obtained.
- Committed to adherence to supplementation and study completion
You may not qualify if:
- Pregnancy
- Chronic medical conditions or medications use that can affect growth, nutrition, bone health, vitamin D metabolism, glucose, or insulin sensitivity
- Known history of hypercalcemia or hypercalciuria
- Non-English speaking, as assessments are available only in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheela N Magge, MD, MSCE
Children's Hospital of Philadelphia
- PRINCIPAL INVESTIGATOR
Andrea Kelly, MD, MSCE
Children's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2012
First Posted
March 7, 2012
Study Start
August 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 23, 2013
Record last verified: 2013-01