Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

Drexel University

Status: Completed

Conditions: Vitamin D Deficiency; Overweight and Obesity; Magnesium Deficiency; Cardiovascular Risk Factor

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Placebo; Dietary Supplement: Vitamin D and magnesium

Study type: Interventional

Funder types: Other

Identifiers

NCT03134417

1407002973

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 3 patient groups, including a placebo group

Vitamin D and magnesium

Experimental group

Description:

Daily oral vitamin D (1000 IU) and magnesium (360 mg) supplement

Treatment:

Dietary Supplement: Vitamin D and magnesium

Vitamin D

Active Comparator group

Description:

Daily oral vitamin D (1000 IU) supplement

Treatment:

Dietary Supplement: Vitamin D

Placebo

Placebo Comparator group

Description:

Daily oral placebo (cellulose)

Treatment:

Dietary Supplement: Placebo