Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

Not Applicable

Completed

• Conditions: Magnesium Deficiency; Vitamin D Deficiency; Cardiovascular Risk Factor; Overweight and Obesity
• Interventions: Dietary Supplement: Vitamin D; Dietary Supplement: Vitamin D and magnesium; Dietary Supplement: Placebo

• Registration Number: NCT03134417
• Lead Sponsor: Drexel University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• BMI range 25-40 kg/m2
• 30-70 years of age

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	Daily oral vitamin D (1000 IU) supplement
Vitamin D and magnesium	Vitamin D and magnesium	Daily oral vitamin D (1000 IU) and magnesium (360 mg) supplement
Placebo	Placebo	Daily oral placebo (cellulose)

Primary Outcome Measures

Name	Time	Method
Serum parathyroid hormone	12 weeks

Secondary Outcome Measures

Name	Time	Method
Lipid profile	12 weeks
Inflammatory cytokines	12 weeks
Blood pressure	12 weeks
Serum osteocalcin	12 weeks

Trial Locations

Locations (1)

Drexel University Nutrition Sciences Research Lab; 🇺🇸 Philadelphia, Pennsylvania, United States