Vitamin D and Vascular Health in Children

This study is currently recruiting participants.
Verified August 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kumaravel Rajakumar, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01797302
First received: February 20, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

In this study, we will test the central hypothesis that enhancement of vitamin D status in obese and overweight children will improve their vascular health and their cardiovascular disease (CVD) and metabolic syndrome risk profile.


Condition Intervention
Obesity
Vitamin D Deficiency
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Vascular Function in Obese Children

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • brachial artery flow-mediated dilation (FMD) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measure of vascular endothelial function


Secondary Outcome Measures:
  • pulse-wave velocity (PWV) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measure of arterial stiffness

  • fasting glucose/fasting insulin ratio [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) as a surrogate estimate of insulin sensitivity


Other Outcome Measures:
  • blood pressure, waist circumference, HDL cholesterol, triglycerides, and fasting blood glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    components of metabolic syndrome

  • inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • adipokines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • nitric oxide metabolites [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: August 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3 2000 IU
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Dietary Supplement: Vitamin D3
Tablet form
Other Name: Cholecalciferol
Active Comparator: Vitamin D3 1000 IU
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Dietary Supplement: Vitamin D3
Tablet form
Other Name: Cholecalciferol
Placebo Comparator: Vitamin D3 600 IU
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Dietary Supplement: Vitamin D3
Tablet form
Other Name: Cholecalciferol

Detailed Description:

Our primary objective is to determine, in obese and overweight children aged 10 to 18 years with vitamin D deficiency (defined as serum 25-hydroxyvitamin D <20 ng/mL), the efficacy of enhanced vitamin D3 supplementation in improving vascular endothelial function, arterial stiffness, insulin sensitivity, and metabolic syndrome risk status; and to assess whether these effects are dose-dependent. As a secondary objective, we will examine the vitamin D supplementation-induced effect on adipokines and inflammatory markers relevant to CVD risk. In a double-masked, controlled trial, we will randomize 252 eligible children to receive either 600 IU (conventional supplementation), or 1000 IU or 2000 IU (enhanced supplementation) of vitamin D3 daily for 6 months.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible subjects will be 10 to 18 years of age;
  • obese or overweight (BMI ≥85th %tile);
  • otherwise healthy, and
  • have a serum 25(OH)D concentration <20 ng/mL

Children taking multivitamins should be able to hold off their multivitamins during the course of the study.

Exclusion Criteria:

Children will be excluded if they

  • (a) have hepatic or renal disease, metabolic rickets, malabsorptive disorders, primary hyperparathyroidism, hyperthyroidism, or other chronic disorders that could affect vitamin D metabolism;
  • (b) are receiving treatment with anticonvulsants, systemic glucocorticoids, pharmacologic doses of vitamin D (≥1000 IU of vitamin D2 or D3 daily), antihypertensives, vasoactive drugs, antilipidemics, metformin, antipsychotics, or other oral insulin regulators;
  • (c) have cholelithiasis or urolithiasis;
  • (d) have type 1 or type 2 diabetes; or
  • (e) have a condition or underlying abnormality that could compromise the safety of the subject.

Post-menarchial girls with a positive pregnancy test at randomization, or subjects found during the screening phase to have hypercalcemia (serum calcium >10.8 mg/dL) or significant fasting hyperglycemia (fasting blood glucose ≥ 125 mg/dL) will also be excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01797302

Contacts
Contact: Flora Olabopo, BS 412-692-8737 flora.olabopo@chp.edu
Contact: Kumaravel Rajakumar, MD, MS 412-692-5415 kumaravel.rajakumar@chp.edu

Locations
United States, Pennsylvania
Primary Care Center, Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Kumaravel Rajakumar, MD, MS         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Kumaravel Rajakumar, MD, MS University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
  More Information

No publications provided

Responsible Party: Kumaravel Rajakumar, Associate Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01797302     History of Changes
Other Study ID Numbers: PRO12100034, R01HL112985
Study First Received: February 20, 2013
Last Updated: August 20, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Pittsburgh:
Obesity
Vitamin D Deficiency
Vascular Function
Insulin resistance
metabolic syndrome

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 April 23, 2014