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NCT03134417 Clinical Trial

Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

Overweight and Obesity Clinical Trial

Official title:
Parathyroid Hormone and Cardiometabolic Outcomes in Obesity: Role of Magnesium and Vitamin D Supplementation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03134417
Other study ID # 1407002973
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date June 1, 2021

Study information
Verified date September 2021
Source Drexel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of a combined vitamin D and magnesium supplementation on parathyroid hormone and cardiometabolic health in persons living with obesity.

Description:

Individuals living with obesity are at a higher risk of cardiometabolic abnormalities and high circulating parathyroid hormone. There is evidence suggesting that vitamin D may play a role in cardiovascular health outcomes; however, the research is currently inconclusive. Magnesium is a cofactor of vitamin D metabolism, and the prevalence of concurrent vitamin D and magnesium deficiency is high. This study aims to investigate the effect of vitamin D and magnesium supplements in individuals who are overweight and obese on parathyroid hormone and cardiometabolic health.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date June 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria: - BMI range 25-40 kg/m2 - 30-70 years of age Exclusion Criteria: - Presence of any acute illness in the past month - Pre-existing chronic medical conditions or medications know to influence energy, vitamin D, magnesium and calcium metabolism, levels of blood glucose, lipids and blood pressure - Individuals taking vitamin D and magnesium supplement greater than the Recommended Daily allowance - Participants taking any medications or have disease known to influence calcium or bone metabolism

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Vitamin D and magnesium
Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.
• Vitamin D
Daily vitamin D supplements are given to participants daily for 12 weeks.
• Placebo
Daily placebo are given to participants daily for 12 weeks.

Locations
Country Name City State
United States Drexel University Nutrition Sciences Research Lab Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Drexel University American Heart Association

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum parathyroid hormone 12 weeks
Secondary Inflammatory cytokines 12 weeks
Secondary Lipid profile 12 weeks
Secondary Blood pressure 12 weeks
Secondary Serum osteocalcin 12 weeks
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