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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756899
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : October 26, 2012
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester

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 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 or disease
Vitamin D Deficiency Obesity

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.

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children
Study Start Date : July 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Chilren with BMI of >95th percentile
Children with BMI of <85th percentile

Primary Outcome Measures :
  1. Bone mineral content [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prepubertal children

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00756899

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

Responsible Party: Benjamin U. Nwosu, Study Principal Investigator, University of Massachusetts, Worcester Identifier: NCT00756899     History of Changes
Other Study ID Numbers: H-12795
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents