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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00603499
Other study ID # 2000-161-0027
Secondary ID IMSS
Status Completed
Phase Phase 4
First received January 16, 2008
Last updated January 16, 2008
Start date July 2006
Est. completion date November 2007

Study information

Verified date January 2008
Source Instituto Mexicano del Seguro Social
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Interventional

Clinical Trial Summary

Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic subjects with decreased serum magnesium levels Design : Randomised double blind placebo controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum magnesium deficiency and uncomplicated hypertension.

Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received inert placebo.

Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary outcomes measures: Changes in lipid profile


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date November 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Decreased serum magnesium levels

- Uncomplicated hypertension

- 40 and 75 years of age

- Men and Women

Exclusion Criteria:

- Chronic diarrhea

- Alcohol intake (equal or more than 30 g per day)

- Use of diuretics and/or calcium antagonists drugs

- Previous oral magnesium supplementation

- Ischemic diseases; AND

- Reduced renal function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Dietary Supplement:
Magnesium chloride
Subjects in the intervention group received 2.5 gr of MgCl2 daily during 4 months, from a solution solution containing 50 gr of MgCl2 by 1000 ml.
Other:
Placebo
Subjects in the control group received inert placebo once per day during 4 months

Locations

Country Name City State
Mexico Biomedical Research Unit Durango

Sponsors (1)

Lead Sponsor Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in the systolic and diastolic blood pressures 2 y Yes
Secondary Average increase of serum magnesium levels Changes in lipid profile 2 y Yes
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