Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

Sponsor

Drexel University (Other)

Overall Status

Completed

CT.gov ID

NCT03134417

Collaborator

American Heart Association (Other)

109

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Vitamin D Deficiency Magnesium Deficiency Cardiovascular Risk Factor	Dietary Supplement: Vitamin D and magnesium Dietary Supplement: Vitamin D Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D and magnesium Daily oral vitamin D (1000 IU) and magnesium (360 mg) supplement	Dietary Supplement: Vitamin D and magnesium Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.
Active Comparator: Vitamin D Daily oral vitamin D (1000 IU) supplement	Dietary Supplement: Vitamin D Daily vitamin D supplements are given to participants daily for 12 weeks.
Placebo Comparator: Placebo Daily oral placebo (cellulose)	Dietary Supplement: Placebo Daily placebo are given to participants daily for 12 weeks.

Arm

Intervention/Treatment

Experimental: Vitamin D and magnesium

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

Dietary Supplement: Vitamin D and magnesium

Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.

Active Comparator: Vitamin D

Daily oral vitamin D (1000 IU) supplement

Dietary Supplement: Vitamin D

Daily vitamin D supplements are given to participants daily for 12 weeks.

Placebo Comparator: Placebo

Daily oral placebo (cellulose)

Dietary Supplement: Placebo

Daily placebo are given to participants daily for 12 weeks.

Outcome Measures

Primary Outcome Measures

Serum parathyroid hormone [12 weeks]

Secondary Outcome Measures

Inflammatory cytokines [12 weeks]
Lipid profile [12 weeks]
Blood pressure [12 weeks]
Serum osteocalcin [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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