ObeseNCT02135913
Roles of Vitamin D and HDL in Obese Children
A study testing Vitamin D in people with Obese and Vitamin D Deficiency, run by Xiang-An Li at 1 site in United States.
Trial summary
This is a pilot study to determine the association between Vitamin D deficiency in obese children and low high density lipoprotein (HDL) and dysfunctional HDL. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Obese, Vitamin D Deficiency, Low HDL
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 26 Apr 2017
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obese children
- Vitamin D deficiency
- Low HDL
Who cannot join
- HIV
- Hepatitis A
- Hepatitis B
- Hepatitis C
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
About this study
This is a pilot study to determine the association between Vitamin D deficiency in obese children and low high density lipoprotein (HDL) and dysfunctional HDL.
Read the detailed description
Subjects will be identified through the Department of Pediatric - High Body Mass Index (BMI) Clinic by Dr. Aurelia Radulescu during standard of care visit. Dr. Radulescu will determine if the subject meets study eligibility requirements.
Visit 1 (Baseline/Screening): Consent/assent will be obtained, medical history, demographic information along with height and weight will be collection. Clinical Laboratory testing, although not part of this study, will include the following standard of care tests. The results of Vitamin D and Lipid profile testing will be shared with Dr. Li by Dr. Radulescu.
- Lipid profile
- Vitamin D
- AST/ALT
- Hb A1C
- Glucose
- CBS w/diff
- TSH
- BUN, Creatine
- UA
Subjects will be placed on standard of care Vitamin D supplementation for 12 weeks.
Visit 2 (3 month visit) End of Study: Subjects will return to the BMI clinic at month 3 for follow-up and additional clinical laboratory testing (see visit 1 for a description of testing to be performed) in order to assess their response to Vitamin D supplementation. Subjects with previously reported abnormal Lipid values will have a Lipid profile repeated at this visit. Month 3 visit will be the End of Study visit.
- Conditions
- Obese, Vitamin D Deficiency, Low HDL
- Being tested
- Vitamin D
- Keywords
- Obese, Children, Vitamin D deficiency, Low HDL
- Medical subject headings
- Obesity, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
All subjects enrolled into the study will be prescribed standard of care Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Viatamin D | Experimental | All children enrolled into the study will be prescribed standard of care vitamin D. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation
Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL
Measured: up to 24 months
Secondary outcomes (1)
Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation
Supplementation of Vitamin D to obese children with low Vitamin D/low HDL corrects Vitamin D deficiency, restores HDL levels and functions.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start1 Jan 2016
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiang-An Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang-An Li, University of Kentucky
- Investigators
- Xiang An-Li, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135913
- Sponsor's protocol ID
- 14-0348-P3H
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles of Vitamin D and HDL in Obese Children
- ClinicalTrials.gov ID
- NCT02135913
- Acronym / sponsor ID
- 14-0348-P3H
- Conditions
- Obese, Vitamin D Deficiency, Low HDL
- Keywords
- Obese, Children, Vitamin D deficiency, Low HDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Xiang-An LiUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 12 May 2014 (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.
This is a pilot study to determine the association between Vitamin D deficiency in obese children and low high density lipoprotein (HDL) and dysfunctional HDL.
Detailed description
Subjects will be identified through the Department of Pediatric - High Body Mass Index (BMI) Clinic by Dr. Aurelia Radulescu during standard of care visit. Dr. Radulescu will determine if the subject meets study eligibility requirements.
Visit 1 (Baseline/Screening): Consent/assent will be obtained, medical history, demographic information along with height and weight will be collection. Clinical Laboratory testing, although not part of this study, will include the following standard of care tests. The results of Vitamin D and Lipid profile testing will be shared with Dr. Li by Dr. Radulescu.
- Lipid profile
- Vitamin D
- AST/ALT
- Hb A1C
- Glucose
- CBS w/diff
- TSH
- BUN, Creatine
- UA
Subjects will be placed on standard of care Vitamin D supplementation for 12 weeks.
Visit 2 (3 month visit) End of Study: Subjects will return to the BMI clinic at month 3 for follow-up and additional clinical laboratory testing (see visit 1 for a description of testing to be performed) in order to assess their response to Vitamin D supplementation. Subjects with previously reported abnormal Lipid values will have a Lipid profile repeated at this visit. Month 3 visit will be the End of Study visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viatamin D | Experimental | Dietary Supplement: Vitamin DAll children enrolled into the study will be prescribed standard of care vitamin D. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Obese children
- Vitamin D deficiency
- Low HDL
Key exclusion criteria (5 listed)
- HIV
- Hepatitis A
- Hepatitis B
- Hepatitis C
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAll subjects enrolled into the study will be prescribed standard of care Vitamin D | Dietary supplement | Viatamin D |
Primary outcome
Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation
Time frame: up to 24 months
Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL
1 secondary outcome
Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation
Time frame: up to 24 months
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 2 May 2017.
Related trials for Obese
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Xiang An-Li, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Obese and Vitamin D Deficiency, run by Xiang-An Li 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 3 inclusion and 5 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 2 May 2017. 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?
Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation (time frame: up to 24 months). 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 2 May 2017.