Vitamin D DeficiencyNCT00851396
Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls
An observational study of Vitamin D Deficiency and Insulin Resistance, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to assess the relationship between vitamin D status and insulin- glucose dynamics in obese Adolescents. The study is intended to assess the difference in the insulin sensitivity before and after correction of vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- Vitamin D Deficiency, Insulin Resistance, Insulin Sensitivity
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Female adolescents who are menarchal BMI is 95th centile, for age and sex
Who may be able to join
- Female adolescents who are menarchal
- BMI is 95th centile, for age and sex
- Patients will be screened for vitamin D deficiency through an existing study.
- Those found to be vitamin D deficient will be given standard treatment of vitamin D deficiency.
- In this study, patients who self report that they had taken the treatment for vitamin D will be screened for serum 25 OH D level
Who cannot join
- Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital , University of Alabama
Birmingham, Alabama, 35233
About this study
Official title: Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls (Assessment of Prevalence of Vitamin D Deficiency in Obese Teenage Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity)
The purpose of the study is to assess the relationship between vitamin D status and insulin- glucose dynamics in obese Adolescents. The study is intended to assess the difference in the insulin sensitivity before and after correction of vitamin D deficiency.
Read the detailed description
The vitamin D deficient subjects are identified initially through an existing study. Those identified with vitamin D deficiency are notified and subsequently treated with standard therapy for vitamin D deficiency as part of their clinical care. Patients who self report that they have taken the treatment are enrolled in this study. Patients will be evaluated in this study with measurement of serum 25 OH D level, PTH and oral glucose tolerance test. The study will assess if there is improvement in glucose- insulin sensitivity dynamics once the serum 25OH D level is normalized
- Conditions
- Vitamin D Deficiency, Insulin Resistance, Insulin Sensitivity, Obesity
- Keywords
- Vitamin D deficiency, Insulin resistance, Glucose- Insulin dynamics, Obese adolescents
- Medical subject headings
- Vitamin D Deficiency, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese female adolescents | Obese adolescents will be screened for vitamin D deficiency through an existing study. Those found to be vitamin D deficient will be given standard treatment of vitamin D deficiency. In this study, patients who self report that they had taken the treatment for vitamin D will be screened for serum 25 OH D level and will undergo OGTT. The OGTT results as well as insulin resistance indices will be compared to their initial values. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study.
Measured: December 2009
Secondary outcomes (1)
We will evaluate whether the relationship of obesity and insulin resistance and the defective insulin secretory capacity is modulated by vitamin D status
Measured: December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambika Ashraf, M.D., University of Alabama at Birmingham
- Investigators
- Ambika Ashraf, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851396
- Sponsor's protocol ID
- F080221001
- Status last verified
- Sep 2011
- First submitted
- 23 Feb 2009
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls (Assessment of Prevalence of Vitamin D Deficiency in Obese Teenage Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity)
- ClinicalTrials.gov ID
- NCT00851396
- Acronym / sponsor ID
- F080221001
- Conditions
- Vitamin D Deficiency, Insulin Resistance, Insulin Sensitivity, Obesity
- Keywords
- Vitamin D deficiency, Insulin resistance, Glucose- Insulin dynamics, Obese adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the relationship between vitamin D status and insulin- glucose dynamics in obese Adolescents. The study is intended to assess the difference in the insulin sensitivity before and after correction of vitamin D deficiency.
Detailed description
The vitamin D deficient subjects are identified initially through an existing study. Those identified with vitamin D deficiency are notified and subsequently treated with standard therapy for vitamin D deficiency as part of their clinical care. Patients who self report that they have taken the treatment are enrolled in this study. Patients will be evaluated in this study with measurement of serum 25 OH D level, PTH and oral glucose tolerance test. The study will assess if there is improvement in glucose- insulin sensitivity dynamics once the serum 25OH D level is normalized
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese female adolescents | – | –Obese adolescents will be screened for vitamin D deficiency through an existing study. Those found to be vitamin D deficient will be given standard treatment of vitamin D deficiency. In this study, patients who self report that they had taken the treatment for vitamin D will be screened for serum 25 OH D level and will undergo OGTT. The OGTT results as well as insulin resistance indices will be compared to their initial values. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female adolescents who are menarchal BMI is 95th centile, for age and sex
Key inclusion criteria (5 listed)
- Female adolescents who are menarchal
- BMI is 95th centile, for age and sex
- Patients will be screened for vitamin D deficiency through an existing study.
- Those found to be vitamin D deficient will be given standard treatment of vitamin D deficiency.
- In this study, patients who self report that they had taken the treatment for vitamin D will be screened for serum 25 OH D level
Key exclusion criteria (1 listed)
- Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study.
Time frame: December 2009
1 secondary outcome
We will evaluate whether the relationship of obesity and insulin resistance and the defective insulin secretory capacity is modulated by vitamin D status
Time frame: December 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ambika Ashraf principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Insulin Resistance, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study. (time frame: December 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2011.