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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014