Vitamin D Deficiency and Low Bone Mineral Content in Children

Obesity Clinical Trial

— VDS  

Official title:

The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756899
• Other study ID #: H-12795
• Status: Completed
• Phase: N/A
• First received: September 18, 2008
• Last updated: October 25, 2012
• Start date: July 2008
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral content		Baseline	No