Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

September 23, 2021 updated by: Drexel University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University Nutrition Sciences Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum parathyroid hormone
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 12 weeks
12 weeks
Inflammatory cytokines
Time Frame: 12 weeks
12 weeks
Lipid profile
Time Frame: 12 weeks
12 weeks
Serum osteocalcin
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Collaborators

American Heart Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

April 7, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1407002973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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