Vitamin D Deficiency and Low Bone Mineral Content in Children (VDS)
|ClinicalTrials.gov Identifier: NCT00756899|
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : October 26, 2012
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.
|Condition or disease|
|Vitamin D Deficiency Obesity|
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.
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Observational Model:||Case Control|
|Official Title:||The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children|
|Study Start Date :||July 2008|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
Chilren with BMI of >95th percentile
Children with BMI of <85th percentile
- Bone mineral content [ Time Frame: Baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|