Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3 (Vitamin D RCT)
The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian children.
We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000 IU/day vs. placebo) initiated during October through March (during fall and winter) in 8 to 14 year old African American and Caucasian children. The results of the trial will help establish the cutoff threshold value of serum 25(OH)D for defining vitamin D insufficiency in preadolescent and adolescent children. Safety of vitamin D supplementation will be assessed by measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse events. Currently recommended adequate intake for vitamin D of 200 IU daily may not meet the body's daily needs for vitamin D. Therefore, it is likely that a higher level of daily vitamin D intake may be needed to meet the body's skeletal and non-skeletal demands for vitamin D. Determining the dietary required intake of vitamin D for the prevention of vitamin D insufficiency during childhood has immense public health potential for addressing health disparities and ensuring better bone health during adulthood. The primary outcome measure will be serum 25(OH)D and parathyroid hormone (PTH). The secondary outcome measures will include: markers of bone formation (serum P1NP) and bone resorption (serum CTX).We will also examine differences in serum 25(OH)D, PTH, and markers of bone turnover in African American vs. Caucasian children.
|Healthy||Dietary Supplement: Vitamin D3 1000 IU Dietary Supplement: Placebo Tablet||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3|
- Serum 25-hydroxyvitamin D [ Time Frame: 6 months ]Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL.
- Parathyroid Hormone (PTH) Dietary Data [ Time Frame: 6 months ]
- Osteocalcin (OC) [ Time Frame: 6 months ]Marker of bone formation
- Collagen Type 1 Cross-linked C-telopeptide (CTx) [ Time Frame: 6 months ]Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.
|Study Start Date:||October 2008|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3
Vitamin D3 1000 IU Tablet
Dietary Supplement: Vitamin D3 1000 IU
Vitamin D3 1000 IU Tablet once daily for 6 months
Placebo Comparator: Placebo
Dietary Supplement: Placebo Tablet
Placebo Tablet once daily for 6 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732758
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15217|
|Principal Investigator:||Kumaravel Rajakumar, MD||University of Pittsburgh|