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VDS: Vitamin D Deficiency and Low Bone Mineral Content in Children

Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Completed
CT.gov ID
NCT00756899
Collaborator
(none)
45
Enrollment
1
Location
46
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jul 1, 2008
    Actual Primary Completion Date :
    May 1, 2012
    Actual Study Completion Date :
    May 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Obese

    Chilren with BMI of >95th percentile
    Non-obese

    Children with BMI of <85th percentile

    Outcome Measures

    Primary Outcome Measures

    1. Bone mineral content [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benjamin U. Nwosu, Study Principal Investigator, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT00756899
    Other Study ID Numbers:
    • H-12795
    First Posted:
    Sep 22, 2008
    Last Update Posted:
    Oct 26, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Benjamin U. Nwosu, Study Principal Investigator, University of Massachusetts, Worcester
    Vitamin D deficiency, insulin resistance, obesity, bone
    Additional relevant MeSH terms:
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Oct 26, 2012