Vitamin D Deficiency and Low Bone Mineral Content in Children - Full Text View

Sponsored by:	University of Massachusetts
Information provided by:	University of Massachusetts
ClinicalTrials.gov Identifier:	NCT00756899

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

MedlinePlus related topics: Minerals Obesity Obesity in Children

Drug Information available for: Vitamin D

U.S. FDA Resources

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

Further study details as provided by University of Massachusetts:

Primary Outcome Measures:

Bone mineral content [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
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

Contacts

Contact: Benjamin U Nwosu, MD	508-334-7872	nwosub@ummhc.org
Contact: Mary M Lee, MD	508-856-4280	leeM@ummhc.org

Locations

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

Sponsors and Collaborators

University of Massachusetts

Investigators

Principal Investigator:	Benjamin U Nwosu, MD	University of Massachusetts Medical School
Study Director:	Carol A Cicarrelli, RN	University of Massachusetts Medical School

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Massachusetts:

Vitamin D deficiency, insulin resistance, obesity, bone

Study placed in the following topic categories:

Vitamin D Deficiency
Obesity
Avitaminosis
Trace Elements
Bone Density Conservation Agents
Overweight
Insulin
Body Weight
Signs and Symptoms

Malnutrition
Vitamin D
Vitamins
Nutrition Disorders
Overnutrition
Micronutrients
Insulin Resistance
Deficiency Diseases

Additional relevant MeSH terms:

Vitamin D Deficiency
Obesity
Avitaminosis
Growth Substances
Physiological Effects of Drugs
Overweight
Bone Density Conservation Agents
Pharmacologic Actions
Body Weight

Signs and Symptoms
Malnutrition
Vitamin D
Vitamins
Nutrition Disorders
Overnutrition
Micronutrients
Deficiency Diseases

ClinicalTrials.gov processed this record on May 07, 2009