Vitamin D Deficiency and Low Bone Mineral Content in Children (VDS)
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|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|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Chilren with BMI of >95th percentile
Children with BMI of <85th percentile
- Bone mineral content [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|