Vitamin D and Vascular Health in Children

NCT01797302 | Completed Results DMC

• 3 other identifiers: PRO12100034R01HL1129855R01HL112985-05
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Vitamin D Deficiency

Keywords

Obesity; Vitamin D Deficiency; Vascular Function; Insulin resistance; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pulse-wave Velocity (PWV)

  6 months

• Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)

  6 months

• Central Systolic Blood Pressure

  6 months

• Central Diastolic Blood Pressure

  6 months

• Systemic Systolic Blood Pressure

  6 months

Other Outcomes (1)

• Body Mass Index (BMI)

  6 months

Study Arms (3)

Vitamin D3 2000 IU

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3

Vitamin D3 1000 IU

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3

Vitamin D3 600 IU

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Tablet form

Also known as: Cholecalciferol

Vitamin D3 1000 IU; Vitamin D3 2000 IU; Vitamin D3 600 IU

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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. Am J Clin Nutr. 2020 Apr 1;111(4):757-768. doi: 10.1093/ajcn/nqz340.

  PMID: 31950134 RESULT

MeSH Terms

Conditions

Obesity; Vitamin D Deficiency; Insulin Resistance; Metabolic Syndrome

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Our findings of reductions in central-systolic BP and fasting glucose concentrations and improvement in insulin sensitivity lack adjustment for multiplicity and therefore should be considered as hypothesis-generating and interpreted with caution.

Results Point of Contact

• Title: Kumaravel Rajakumar
• Organization: University of Pittsburgh School of Medicine

kumaravel.rajakumar@chp.edu

412-692-5822

Study Officials

• Kumaravel Rajakumar, MD, MS

  University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: August 1, 2013
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: June 24, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-06

Locations

US (1)