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Completed

NCT Number: NCT03134417

Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

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.

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Key information

Conditions

Overweight and Obesity Avitaminosis Body Weight Cardiovascular Risk Factor Deficiency Diseases Magnesium Deficiency Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin D Deficiency

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University Nutrition Sciences Research Lab

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D and magnesium

Dietary Supplement

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

Vitamin D

Dietary Supplement

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

Placebo

Dietary Supplement

Daily placebo are given to participants daily for 12 weeks.

Primary outcomes

  1. Serum parathyroid hormone

    Time frame: 12 weeks

Secondary outcomes

  1. Inflammatory cytokines

    Time frame: 12 weeks

  2. Lipid profile

    Time frame: 12 weeks

  3. Blood pressure

    Time frame: 12 weeks

  4. Serum osteocalcin

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
May 1, 2017
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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