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Sponsored by: |
University of Massachusetts |
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Information provided by: | University of Massachusetts |
ClinicalTrials.gov Identifier: | NCT00756899 |
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 |
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Vitamin D Deficiency Obesity |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children |
Estimated Enrollment: | 50 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Obese
Chilren with BMI of >95th percentile
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Non-obese
Children with BMI of <85th percentile
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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.
Ages Eligible for Study: | 3 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Prepubertal children
Inclusion Criteria:
Exclusion Criteria:
Contact: Benjamin U Nwosu, MD | 508-334-7872 | nwosub@ummhc.org |
Contact: Mary M Lee, MD | 508-856-4280 | leeM@ummhc.org |
United States, Massachusetts | |
University of Massachusetts Medical School | Recruiting |
Worcester, Massachusetts, United States, 01655 | |
Contact: Benjamin U Nwosu, MD 508-334-7872 nwosub@ummhc.org | |
Contact: Mary M Lee, MD 508-856-4287 LeeM@ummhc.org | |
Principal Investigator: Benjamin U Nwosu, MD | |
Sub-Investigator: Mary M Lee, MD | |
Sub-Investigator: Olga T Hardy, MD | |
Sub-Investigator: Leslie A Soyka, MD | |
Sub-Investigator: Amanda Angelescu, MD | |
Sub-Investigator: Lynn Norris, PA | |
Sub-Investigator: Peter Simkin, MD | |
Sub-Investigator: Carol A Ciccarelli, RN |
Principal Investigator: | Benjamin U Nwosu, MD | University of Massachusetts Medical School |
Study Director: | Carol A Cicarrelli, RN | University of Massachusetts Medical School |
Responsible Party: | University of Massachusetts Medical School ( Benjamin U. Nwosu, MD ) |
Study ID Numbers: | H-12795 |
Study First Received: | September 18, 2008 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00756899 |
Health Authority: | United States: Institutional Review Board |
Vitamin D deficiency, insulin resistance, obesity, bone |
Vitamin D Deficiency Obesity Avitaminosis Ergocalciferols Overweight Insulin Body Weight |
Signs and Symptoms Malnutrition Vitamin D Nutrition Disorders Overnutrition Insulin Resistance Deficiency Diseases |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |