Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-006349
NCT ID: NCT01746264
Sponsor Protocol Number: 12-006349
About this study
Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents have a high prevalence of Vitamin D deficiency as well as evidence of endothelial dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with Vitamin D would lead to improvement in endothelial dysfunction.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 12-18 years
- BMI >95% for age and gender
- 25 (OH) D levels less than 30 ng/ml
Exclusion Criteria:
- 25 (OH) D levels >30 ng/mL
- Serum calcium >10.4 mg/dL
- Serum phosphorus > 4.7 mg/dl
- Pregnancy or nursing
- Current cancer
- Patients on vitamin D3 supplementation exceeding 400 IU/day
- Hypertension defined as Blood Pressure over the 95th percentile for age, gender and height
- Dietary calcium intake exceeding 1500 mg/day,
- Hepatic or renal disorders
- Type 1 or type 2 diabetes mellitus
- Subjects receiving insulin, metformin, or oral hypoglycemic medications
- Subjects with malabsorption disorders (celiac disease, cystic fibrosis,inflammatory bowel disease)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Seema Kumar, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available