NCT01746264

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 2, 2016

Completed
Last Updated

May 2, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

November 16, 2012

Results QC Date

January 25, 2016

Last Update Submit

March 30, 2016

Conditions

ObesityEndothelial DysfunctionVitamin D Deficiency

Keywords

ObesityEndothelial dysfunctionVitamin D deficiency

Outcome Measures

Primary Outcomes (1)

  • Flow Mediated Dilatation (FMD)

    Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.

    baseline, 3 months

Secondary Outcomes (15)

  • 25-hydroxy Vitamin D (25[OH]D) Levels

    baseline, 3 months

  • Total Cholesterol

    baseline, 3 months

  • Triglycerides

    baseline, 3 months

  • Body Mass Index

    baseline, 3 months

  • International Physical Activity Questionnaire (IPAQ) Short Form Score

    baseline, 3 months

  • +10 more secondary outcomes

Study Arms (1)

Vitamin D3

EXPERIMENTAL

Vitamin D3 supplementation at 100,000 IU once a month for 3 months

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Vitamin D 3 at 100,000 IU once a month for 3 months

Also known as: Cholecalciferol
Vitamin D3

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-18 years
  • BMI \>95% for age and gender
  • (OH) D levels less than 30 ng/ml

You may not qualify if:

  • (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Javed A, Kullo IJ, Balagopal PB, Kumar S. Effect of vitamin D3 treatment on endothelial function in obese adolescents. Pediatr Obes. 2016 Aug;11(4):279-84. doi: 10.1111/ijpo.12059. Epub 2015 Aug 14.

    PMID: 26273791RESULT

MeSH Terms

Conditions

ObesityVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutrition

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Seema Kumar
Organization
Mayo Clinic
Kumar.Seema@mayo.edu
507-538-2724

Study Officials

  • Seema Kumar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 16, 2012

First Posted

December 10, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 2, 2016

Results First Posted

May 2, 2016

Record last verified: 2016-03

Locations

US(1)