Trials / Completed
CompletedNCT00756899
Vitamin D Deficiency and Low Bone Mineral Content in Children
The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (actual)
- Sponsor
- University of Massachusetts, Worcester · Academic / Other
- Sex
- All
- Age
- 3 Years – 12 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2008-09-22
- Last updated
- 2012-10-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00756899. Inclusion in this directory is not an endorsement.