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Vitamin D and Vascular Health in Children

This study is currently recruiting participants.
Verified March 2017 by Kumaravel Rajakumar, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797302
First Posted: February 22, 2013
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Kumaravel Rajakumar, University of Pittsburgh
February 20, 2013
February 22, 2013
March 13, 2017
August 2013
January 2018   (Final data collection date for primary outcome measure)
brachial artery flow-mediated dilation (FMD) [ Time Frame: 6 months ]
measure of vascular endothelial function
Same as current
Complete list of historical versions of study NCT01797302 on ClinicalTrials.gov Archive Site
  • pulse-wave velocity (PWV) [ Time Frame: 6 months ]
    measure of arterial stiffness
  • fasting glucose/fasting insulin ratio [ Time Frame: 6 months ]
    Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) as a surrogate estimate of insulin sensitivity
Same as current
  • blood pressure, waist circumference, HDL cholesterol, triglycerides, and fasting blood glucose [ Time Frame: 6 months ]
    components of metabolic syndrome
  • inflammatory markers [ Time Frame: 6 months ]
  • adipokines [ Time Frame: 6 months ]
  • nitric oxide metabolites [ Time Frame: 6 months ]
Same as current
 
Vitamin D and Vascular Health in Children
Vitamin D and Vascular Function in Obese Children
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Vitamin D Deficiency
Dietary Supplement: Vitamin D3
Tablet form
Other Name: Cholecalciferol
  • Active Comparator: Vitamin D3 2000 IU
    Vitamin D3 2000 IU tablet once daily by mouth for 6 months
    Intervention: Dietary Supplement: Vitamin D3
  • Active Comparator: Vitamin D3 1000 IU
    Vitamin D3 1000 IU tablet by mouth once daily for 6 months
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Vitamin D3 600 IU
    Vitamin D3 600 IU tablet by mouth once daily for 6 months
    Intervention: Dietary Supplement: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
252
October 2018
January 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
Yes
Contact: Flora Olabopo, BS 412-692-8737 flora.olabopo@chp.edu
Contact: Kumaravel Rajakumar, MD, MS 412-692-5415 kumaravel.rajakumar@chp.edu
United States
 
 
NCT01797302
PRO12100034
R01HL112985 ( U.S. NIH Grant/Contract )
5R01HL112985-05 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Kumaravel Rajakumar, University of Pittsburgh
University of Pittsburgh
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Office of Dietary Supplements (ODS)
Principal Investigator: Kumaravel Rajakumar, MD, MS University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
University of Pittsburgh
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP