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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850694
• Other study ID #: F061228001
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: April 7, 2017
• Start date: February 2007
• Est. completion date: October 2010

Study information

• Verified date: September 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	Children's Hospital, Universiy of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents.		At study entry
Secondary	To assess the relationship of serum 25 (OH) D statuses to insulin and glucose concentrations during an OGTT and to serum transaminases and CRP.		At study entry