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Vitamin D and Vascular Health in Children

Primary Purpose

Obesity, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Vitamin D Deficiency, Vascular Function, Insulin resistance, metabolic syndrome

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Primary Care Center, Children's Hospital of Pittsburgh of UPMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3 2000 IU

Vitamin D3 1000 IU

Vitamin D3 600 IU

Arm Description

Vitamin D3 2000 IU tablet once daily by mouth for 6 months

Vitamin D3 1000 IU tablet by mouth once daily for 6 months

Vitamin D3 600 IU tablet by mouth once daily for 6 months

Outcomes

Primary Outcome Measures

Flow-mediated Dilation (FMD) Percentage
Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.

Secondary Outcome Measures

Pulse-wave Velocity (PWV)
PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness.
Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)
AIx-75 is a measure of arterial stiffness. AIx was measured through radial arterial tonometry using SphygmoCor. Radial pulse waveform are analyzed through an automatic software function to determine aortic pulse waveform and aortic or central systolic (cSBP) and diastolic blood pressure (cDBP), and these measurements are further analyzed automatically to calculate AIx. AIx is a composite measure of the magnitude of wave reflection and arterial stiffness in all conduit arteries which affect the timing of the wave reflection. AIx = P2-P1/cSBP-cDBP, where P1 is the height of the incident pressure wave form during systole, P2 is the height of the reflected wave added to the incident wave, cSBP is the aortic systolic BP, and cDBP is the aortic diastolic BP. AIx adjusted to heart rate of 75 beats/min (AIx-75) is a validated index of arterial stiffness, with higher values indicating higher degree of arterial stiffness.
Central Systolic Blood Pressure
a measure of cardiometabolic health
Central Diastolic Blood Pressure
a measure of cardiometabolic health
Systemic Systolic Blood Pressure
a measure of cardiometabolic health
Systemic Diastolic Blood Pressure
a measure of cardiometabolic health
Fasting Blood Glucose
a measure of cardiometabolic health
1/Fasting Insulin Ratio
1/fasting insulin ratio is a measure of insulin sensitivity. Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity.

Full Information

First Posted
February 20, 2013
Last Updated
June 10, 2020
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT01797302
Brief Title
Vitamin D and Vascular Health in Children
Official Title
Vitamin D and Vascular Function in Obese Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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. In terms of reporting of results, the following pre-specified outcomes are included in the primary manuscript (PubMed PMID:31950134 -- see Reference section for citation details) Waist Circumference Serum High Density Lipoprotein (HDL) Cholesterol Serum Triglycerides Inflammatory markers (Plasma TNF-alpha, high-sensitivity C-reactive protein, and IL-6) Adiopkines (Plasma Leptin and Adiponectin) Plasma nitric oxide metabolites were not measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Vitamin D Deficiency
Keywords
Obesity, Vitamin D Deficiency, Vascular Function, Insulin resistance, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 2000 IU
Arm Type
Active Comparator
Arm Description
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Arm Title
Vitamin D3 1000 IU
Arm Type
Active Comparator
Arm Description
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Arm Title
Vitamin D3 600 IU
Arm Type
Placebo Comparator
Arm Description
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Tablet form
Primary Outcome Measure Information:
Title
Flow-mediated Dilation (FMD) Percentage
Description
Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pulse-wave Velocity (PWV)
Description
PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness.
Time Frame
6 months
Title
Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)
Description
AIx-75 is a measure of arterial stiffness. AIx was measured through radial arterial tonometry using SphygmoCor. Radial pulse waveform are analyzed through an automatic software function to determine aortic pulse waveform and aortic or central systolic (cSBP) and diastolic blood pressure (cDBP), and these measurements are further analyzed automatically to calculate AIx. AIx is a composite measure of the magnitude of wave reflection and arterial stiffness in all conduit arteries which affect the timing of the wave reflection. AIx = P2-P1/cSBP-cDBP, where P1 is the height of the incident pressure wave form during systole, P2 is the height of the reflected wave added to the incident wave, cSBP is the aortic systolic BP, and cDBP is the aortic diastolic BP. AIx adjusted to heart rate of 75 beats/min (AIx-75) is a validated index of arterial stiffness, with higher values indicating higher degree of arterial stiffness.
Time Frame
6 months
Title
Central Systolic Blood Pressure
Description
a measure of cardiometabolic health
Time Frame
6 months
Title
Central Diastolic Blood Pressure
Description
a measure of cardiometabolic health
Time Frame
6 months
Title
Systemic Systolic Blood Pressure
Description
a measure of cardiometabolic health
Time Frame
6 months
Title
Systemic Diastolic Blood Pressure
Description
a measure of cardiometabolic health
Time Frame
6 months
Title
Fasting Blood Glucose
Description
a measure of cardiometabolic health
Time Frame
6 months
Title
1/Fasting Insulin Ratio
Description
1/fasting insulin ratio is a measure of insulin sensitivity. Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Body Mass Index (BMI)
Description
a surrogate measure of adiposity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kumaravel Rajakumar, MD, MS
Organizational Affiliation
University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Care Center, Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31950134
Citation
Rajakumar K, Moore CG, Khalid AT, Vallejo AN, Virji MA, Holick MF, Greenspan SL, Arslanian S, Reis SE. Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial. Am J Clin Nutr. 2020 Apr 1;111(4):757-768. doi: 10.1093/ajcn/nqz340.
Results Reference
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Vitamin D and Vascular Health in Children

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