Status:
COMPLETED
Vitamin D Deficiency and Low Bone Mineral Content in Children
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Vitamin D Deficiency
Obesity
Eligibility:
All Genders
3-12 years
Brief 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 l...
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00756899
Start Date
July 1 2008
End Date
May 1 2012
Last Update
October 26 2012
Active Locations (1)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655