Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D and magnesium
* Dietary Supplement: Vitamin D
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D and magnesium<br>Daily oral vitamin D (1000 IU) and magnesium (360 mg) supplement | Dietary Supplement: Vitamin D and magnesium<br>* Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.<br>|
| Active Comparator: Vitamin D<br>Daily oral vitamin D (1000 IU) supplement | Dietary Supplement: Vitamin D<br>* Daily vitamin D supplements are given to participants daily for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Daily oral placebo (cellulose) | Dietary Supplement: Placebo<br>* Daily placebo are given to participants daily for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum parathyroid hormone |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory cytokines |  | 12 weeks | 
| Lipid profile |  | 12 weeks | 
| Blood pressure |  | 12 weeks | 
| Serum osteocalcin |  | 12 weeks |