Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes
Parathyroid Hormone and Cardiometabolic Outcomes in Obesity: Role of Magnesium and Vitamin D Supplementation
1 other identifier
interventional
109
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 27, 2021
September 1, 2021
4.9 years
April 7, 2017
September 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Serum parathyroid hormone
12 weeks
Secondary Outcomes (4)
Inflammatory cytokines
12 weeks
Lipid profile
12 weeks
Blood pressure
12 weeks
Serum osteocalcin
12 weeks
Study Arms (3)
Vitamin D and magnesium
EXPERIMENTALDaily oral vitamin D (1000 IU) and magnesium (360 mg) supplement
Vitamin D
ACTIVE COMPARATORDaily oral vitamin D (1000 IU) supplement
Placebo
PLACEBO COMPARATORDaily oral placebo (cellulose)
Interventions
Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.
Daily vitamin D supplements are given to participants daily for 12 weeks.
Eligibility Criteria
You may qualify if:
- BMI range 25-40 kg/m2
- years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Drexel Universitylead
- American Heart Associationcollaborator
Study Sites (1)
Drexel University Nutrition Sciences Research Lab
Philadelphia, Pennsylvania, 19102, United States
Related Publications (1)
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.
PMID: 36640582DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2017
First Posted
May 1, 2017
Study Start
February 1, 2016
Primary Completion
December 31, 2020
Study Completion
June 1, 2021
Last Updated
September 27, 2021
Record last verified: 2021-09