Back to resultsMagnesium and Vitamin D Supplementation and Cardiometabolic Outcomes
Primary Purpose
Overweight and Obesity, Vitamin D Deficiency, Magnesium Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D and magnesium
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- Drexel University Nutrition Sciences Research Lab
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Vitamin D and magnesium
Vitamin D
Placebo
Arm Description
Daily oral vitamin D (1000 IU) and magnesium (360 mg) supplement
Daily oral vitamin D (1000 IU) supplement
Daily oral placebo (cellulose)
Outcomes
Primary Outcome Measures
Serum parathyroid hormone
Secondary Outcome Measures
Inflammatory cytokines
Lipid profile
Blood pressure
Serum osteocalcin
Full Information
NCT ID
NCT03134417
First Posted
April 7, 2017
Last Updated
September 23, 2021
Sponsor
Drexel University
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT03134417
Brief Title
Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes
Official Title
Parathyroid Hormone and Cardiometabolic Outcomes in Obesity: Role of Magnesium and Vitamin D Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
American Heart Association
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Vitamin D Deficiency, Magnesium Deficiency, Cardiovascular Risk Factor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D and magnesium
Arm Type
Experimental
Arm Description
Daily oral vitamin D (1000 IU) and magnesium (360 mg) supplement
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Daily oral vitamin D (1000 IU) supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily oral placebo (cellulose)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and magnesium
Intervention Description
Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Daily vitamin D supplements are given to participants daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily placebo are given to participants daily for 12 weeks.
Primary Outcome Measure Information:
Title
Serum parathyroid hormone
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Inflammatory cytokines
Time Frame
12 weeks
Title
Lipid profile
Time Frame
12 weeks
Title
Blood pressure
Time Frame
12 weeks
Title
Serum osteocalcin
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Drexel University Nutrition Sciences Research Lab
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes
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