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Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00850694
First received: February 23, 2009
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents. The investigators hypothesize vitamin D deficiency will be highly prevalent in obese adolescents and those who are vitamin D deficient will be more insulin resistant.


Condition
Vitamin D Deficiency
Obesity
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Prevalence of Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents. [ Time Frame: At study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the relationship of serum 25 (OH) D statuses to insulin and glucose concentrations during an OGTT and to serum transaminases and CRP. [ Time Frame: At study entry ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Obese female adolescents

Detailed Description:

This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance indices.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obese female adolescents

Criteria

Inclusion Criteria:

  • Female adolescents
  • Obese: BMI > 95th percentile
  • Menarchal
  • Tanner stage ≥ 4

Exclusion Criteria:

  • Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications
  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: NCT00850694

Locations
United States, Alabama
Children's Hospital, Universiy of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Ambika Ashraf University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Ambika Ashraf, M.D., Assistant Professor, Pediatrics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00850694     History of Changes
Other Study ID Numbers: F061228001
Study First Received: February 23, 2009
Last Updated: September 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Vitamin D deficiency
Obesity
Insulin resistance
Glucose tolerance

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Vitamin D Deficiency
Avitaminosis
Body Weight
Deficiency Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Malnutrition
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Ergocalciferols
Insulin
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Hypoglycemic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014