Magnesium Lactate in the Reduction of Gestational Diabetes Incidence.

September 27, 2023 updated by: Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico

Efficiency and Safety of Magnesium Lactate Administration in the Reduction of Gestational Diabetes Incidence.

Gestational diabetes, occurs during the second or third trimester of pregnancy, with no prior history of diabetes; this entity can be resolved at the end of pregnancy. Magnesium is the fourth most abundant mineral in the body, It plays an essential role in the regulation of insulin metabolism, in the functions of adenosine triphosphate. In Mexico, the prevalence of hypomagnesemia is 36.3% for women. Findings suggesting that magnesium supplementation may be a beneficial indication in metabolic glucose disorders. The hypothesis of this study is: that Magnesium lactate administration is safe and reduces the incidence of gestational diabetes.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Objective: This study aims to evaluate the efficacy and safety of magnesium lactate oral administration in reducing the gestational diabetes incidence.

Design: Randomized, double-blind, placebo-controlled clinical trial.

Study population: Pregnant women aged 19 to 35 years, in the twelfth week of pregnancy, whit hypomagnesemia and without the concomitant disease.

Study groups: an intervention group and a control group.

Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05; 15% of the difference in the mean of gestational diabetes incidence control group and intervention groups was considered. The estimated sample size was 110 subjects for each group.

Process: All eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups.

The intervention group will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement; the control group will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.

The blood concentrations of glucose, triglycerides, magnesium, creatinine, transaminases, and thyroid hormones will be measured, as well as the anthropometric measurements, at baseline and end conditions. Also, an oral glucose tolerance curve will be realized at the 20th gestation week.

Statistical analysis: Numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. Differences between the groups were estimated by unpaired Student t-test for numerical variables (Mann-Whitney U test for skewed data) or Chi-square and Fisher´s exact test for categorical variables. Intragroup differences were estimated by paired Student t-test.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Dgo
      • Durango, Dgo, Mexico, 34067
        • Biomedical Research Unit. IMSS. Durango

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 31 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women aged 19 to 35 years.
  • 12th to 14th gestation weeks.
  • Informed consent of the participant.

Exclusion Criteria:

  • Diabetes.
  • High blood pressure.
  • Hypertriglyceridemia (>250 g/dL)
  • Neoplasia disease.
  • Thyroid disease.
  • Hepatic disease.
  • Consumption of alcoholic beverages.
  • Smoking.
  • Medication use (thiazide diuretics, anti-blocking agents, calcium antagonists, statins, nicotinic acid, phenytoin, valproic acid, antidepressants, beta-adrenergic, theophylline, glucocorticoids, in the last year)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium
Magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement.
Dietary supplement: Magnesium lactate.
2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months
Placebo Comparator: Control
2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
Dietary supplement: Placebo
2 tablets orally every 12 hours of on inert placebo for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased of gestational diabetes incidence
Time Frame: Three months.
The incidence of gestational diabetes will be considered as a decrease, at the small proportion difference of less than 13.4% between the incidence of gestational diabetes in the intervention group and the placebo group.
Three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Investigators

  • Principal Investigator: Fernando PD Guerrero, Instituto Mexicano del Seguro Social
  • Study Chair: Luis PD Simental, Instituto Mexicano del Seguro Social
  • Study Chair: Gerardo PD Martínez, Instituto Mexicano del Seguro Social
  • Study Chair: Cludia PD Gamboa, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2022

Primary Completion (Actual)

July 31, 2022

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2019-785-040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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