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Vitamin D Deficiency and Low Bone Mineral Content in Children (VDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00756899
First received: September 18, 2008
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  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.


Condition
Vitamin D Deficiency
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Bone mineral content [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: July 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese
Chilren with BMI of >95th percentile
Non-obese
Children with BMI of <85th percentile

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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Prepubertal children

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756899

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Benjamin U Nwosu, MD University of Massachusetts, Worcester
Study Director: Carol A Cicarrelli, RN University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Benjamin U. Nwosu, Study Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00756899     History of Changes
Other Study ID Numbers: H-12795
Study First Received: September 18, 2008
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Vitamin D deficiency, insulin resistance, obesity, bone

Additional relevant MeSH terms:
Obesity
Vitamin D Deficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
 Malnutrition
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013