Vitamin D and Vascular Health in Children

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on July 31, 2014