Vitamin D Deficiency and Low Bone Mineral Content in Children (VDS)
The Vitamin D study is designed to investigate the effect of body fat mass on vitamin D levels in children. Earlier studies have shown that individuals with increased fat mass may have low vitamin D levels.
Our specific hypothesis states that children with increased fat mass will have lower blood levels of vitamin D when compared to non-obese children.Since vitamin D is the primary hormone for bone mineralization in humans, low levels of vitamin D could lead to decreased bone mineral content in these children.
Vitamin D Deficiency
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children|
- Bone mineral content [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Chilren with BMI of >95th percentile
Children with BMI of <85th percentile
Fifty prepubertal male and female children of ages between 3-12 years will participate in this study. Of these, 25 obese children will be enrolled in the study group, and 25 non-obese children will serve as controls.
All subjects will fill out a comprehensive mineral intake questionnaire as part of the study to ensure adequate calcium intake prior to the study.
All subjects will collect a first morning urine sample for calcium, creatinine, and NTX.
Fasting blood samples will be drawn for the following analytes: 25-hydroxyvitamin D, 1, 25-dihydroxyvitamin D, intact PTH, calcium, phosphorus, magnesium, osteocalcin, insulin, c-peptide, fasting blood glucose, leptin, and adiponectin.
Bone Mineral Content will be evaluated in 16 obese subjects with vitamin D level of < 30 nmol/L.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756899
|United States, Massachusetts|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Benjamin U Nwosu, MD||University of Massachusetts, Worcester|
|Study Director:||Carol A Cicarrelli, RN||University of Massachusetts, Worcester|