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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.

Vitamin D Deficiency and Low Bone Mineral Content in Children (NCT00756899) · Clinical Trials Directory