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Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03134417
Enrollment
109
Registered
2017-05-01
Start date
2016-02-01
Completion date
2021-06-01
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Magnesium Deficiency, Overweight and Obesity, Vitamin D Deficiency

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.

Interventions

DIETARY_SUPPLEMENTVitamin D and magnesium

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

DIETARY_SUPPLEMENTVitamin D

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

DIETARY_SUPPLEMENTPlacebo

Daily placebo are given to participants daily for 12 weeks.

Sponsors

American Heart Association
CollaboratorOTHER
Drexel University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Serum parathyroid hormone12 weeks

Secondary

MeasureTime frame
Inflammatory cytokines12 weeks
Lipid profile12 weeks
Blood pressure12 weeks
Serum osteocalcin12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026