Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

Obesity Clinical Trial

Official title:

Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746264
• Other study ID #: 12-006349
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2012
• Last updated: May 31, 2014
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Obesity
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Vitamin D 3 at 100,000 IU once a month for 3 months

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in flow mediated dilatation (FMD)	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.	baseline to 3 months	No