Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

NCT ID: NCT03134417

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity Vitamin D Deficiency Magnesium Deficiency Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vitamin D and magnesium

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

Group Type EXPERIMENTAL

Vitamin D and magnesium

Intervention Type DIETARY_SUPPLEMENT

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

Vitamin D

Daily oral vitamin D (1000 IU) supplement

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Daily oral placebo (cellulose)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Daily placebo are given to participants daily for 12 weeks.

Interventions

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Vitamin D and magnesium

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

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily placebo are given to participants daily for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Drexel University Nutrition Sciences Research Lab

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Dall RD, Cheung MM, Shewokis PA, Altasan A, Volpe SL, Amori R, Singh H, Sukumar D. Combined vitamin D and magnesium supplementation does not influence markers of bone turnover or glycemic control: A randomized controlled clinical trial. Nutr Res. 2023 Feb;110:33-43. doi: 10.1016/j.nutres.2022.12.005. Epub 2022 Dec 22.

Reference Type DERIVED
PMID: 36640582 (View on PubMed)

Other Identifiers

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1407002973

Identifier Type: -

Identifier Source: org_study_id

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