Vitamin D and Vascular Health in Children

Obesity Clinical Trial

Official title:

Vitamin D and Vascular Function in Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797302
• Other study ID #: PRO12100034
• Secondary ID: R01HL1129855R01H
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: August 13, 2018

Study information

• Verified date: June 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

1. Waist Circumference

2. Serum High Density Lipoprotein (HDL) Cholesterol

3. Serum Triglycerides

4. Inflammatory markers (Plasma TNF-alpha, high-sensitivity C-reactive protein, and IL-6)

5. Adiopkines (Plasma Leptin and Adiponectin)

Plasma nitric oxide metabolites were not measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Tablet form

Locations

Country	Name	City	State
United States	Primary Care Center, Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index (BMI)	a surrogate measure of adiposity	6 months
Primary	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.	6 months
Secondary	Pulse-wave Velocity (PWV)	PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness.	6 months
Secondary	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.	6 months
Secondary	Central Systolic Blood Pressure	a measure of cardiometabolic health	6 months
Secondary	Central Diastolic Blood Pressure	a measure of cardiometabolic health	6 months
Secondary	Systemic Systolic Blood Pressure	a measure of cardiometabolic health	6 months
Secondary	Systemic Diastolic Blood Pressure	a measure of cardiometabolic health	6 months
Secondary	Fasting Blood Glucose	a measure of cardiometabolic health	6 months
Secondary	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.	6 months