Expired Study
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Worcester, Massachusetts 01655


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - General: Prepubertal children (males, with testicular volume of ≤ 3 cc, and girls with Tanner 1 breast) of ages 7-11 years will be enrolled in the study. - Study group: Subjects with a BMI of > 95th percentile for age and sex. - Control group: All control subjects will have a BMI of < 85th percentile for age and sex. Exclusion Criteria: - known metabolic or genetic diseases resulting in obesity such as severe hypothyroidism, pseudohypoparathyroidism, or Cushing's disease - diabetes mellitus - subjects on lipid lowering medications - subjects on medications known to impact body weight or calcium homeostasis - subjects with a history of recent significant weight loss or gain


NCT ID:

NCT00756899


Primary Contact:

Principal Investigator
Benjamin U Nwosu, MD
University of Massachusetts, Worcester


Backup Contact:

N/A


Location Contact:

Worcester, Massachusetts 01655
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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