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Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Seema Kumar, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01746264
First received: November 16, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
Endothelial Dysfunction
Vitamin D Deficiency
 Dietary Supplement: Vitamin D3
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Obesity Vitamin D
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in flow mediated dilatation (FMD) [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Endothelial function will be assessed by FMD. Flow mediated dilatation (FMD) will be calculated as the maximal percentage increase in Brachial artery diameter (BAD) from baseline after the release of cuff occlusion.


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Vitamin D supplementation at 100,000 IU once a month for 3 months
 Dietary Supplement: Vitamin D3
Vitamin D 3 at 100,000 IU once a month for 3 months

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 12-18 years
  2. BMI >95% for age and gender
  3. 25 (OH) D levels less than 30 ng/ml

Exclusion Criteria:

  1. 25 (OH) D levels >30 ng/mL
  2. Serum calcium >10.4 mg/dL
  3. Serum phosphorus > 4.7 mg/dl
  4. Pregnancy or nursing
  5. Current cancer
  6. Patients on vitamin D3 supplementation exceeding 400 IU/day
  7. Hypertension defined as Blood Pressure over the 95th percentile for age, gender and height
  8. Dietary calcium intake exceeding 1500 mg/day,
  9. Hepatic or renal disorders
  10. Type 1 or type 2 diabetes mellitus
  11. Subjects receiving insulin, metformin, or oral hypoglycemic medications
  12. Subjects with malabsorption disorders (celiac disease, cystic fibrosis,inflammatory bowel disease)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746264

Contacts
Contact: Asma Javed, MBBS 507-284-3300 javed.asma@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Asma Javed, MBBS     507-284-3300     javed.asma@mayo.edu    
Sub-Investigator: Asma Javed, MBBS            
Principal Investigator: Seema Kumar, MD            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Seema Kumar, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Seema Kumar, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01746264     History of Changes
Other Study ID Numbers: 12-006349
Study First Received: November 16, 2012
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Obesity
Endothelial dysfunction
Vitamin D deficiency

Additional relevant MeSH terms:
Obesity
Vitamin D Deficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
 Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013