NCT00850694

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 10, 2017

Status Verified

September 1, 2011

Enrollment Period

3.7 years

First QC Date

February 23, 2009

Last Update Submit

April 7, 2017

Conditions

Vitamin D DeficiencyObesityInsulin Resistance

Keywords

Vitamin D deficiencyObesityInsulin resistanceGlucose tolerance

Outcome Measures

Primary Outcomes (1)

  • To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents.

    At study entry

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

Obese female adolescents

Eligibility Criteria

Age10 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese female adolescents

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Universiy of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Vitamin D DeficiencyObesityInsulin Resistance

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Ambika Ashraf

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Pediatrics

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

February 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 10, 2017

Record last verified: 2011-09

Locations

US(1)