The Effect of Folic Acid Administration in the Progression of Microalbuminuria

August 18, 2008 updated by: Hospital Universitario Dr. Jose E. Gonzalez

Folic Acid Administration Reduces the Progression of Microalbuminuria

The development of diabetic nephropathy has been linked to several genetic polymorphisms, including those related with homocysteine metabolism such as the methylenetetrahydrofolate reductase (MTHFR)and the cystathionine-beta-synthase genes. Such alterations are associated with hyperhomocysteinemia, which is a known independent risk factor for the development of endothelial dysfunction and cardiovascular disease.

In the Mexican population there is a high prevalence of the C677T MTHFR mutation. The investigators performed this study to evaluate the prevalence of this polymorphism in type 2 diabetic patients with diabetic nephropathy compared with type 2 diabetic patients without nephropathy, besides evaluating the relationship of hyperhomocysteinemia with endothelial dysfunction and microalbuminuria before and after the administration of folic acid. We proposed that the endothelial dysfunction caused by the hyperhomocysteinemia could be reversed after the administration of folic acid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "José E. González"

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus patients with 5 to 15 years of diagnosis
  • Microalbuminuria (defined as a urinary albumin/creatinine ratio between 30 and 300 mg/g)
  • A1c less than 9% in the last year

Exclusion Criteria:

  • Acute diabetic complications
  • A1c greater than 9% in the last year
  • Acute infectious process
  • Hepatic disease
  • Thyroid disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Administration of an oral placebo pill
Drug: Placebo
Administration of an oral placebo pill
Experimental: 2
Administration of oral folic acid
Drug: Folic acid
Administration of a daily tablet containing 5 mg of folic acid for 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in albumin excretion rate
Time Frame: Four months
Four months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum homocysteine, thrombomodulin and von Willebrand factor.
Time Frame: Four months.
Four months.

Collaborators and Investigators

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

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Collaborators

Laboratorios Valdecasas S.A.

Investigators

  • Study Chair: Fernando J Lavalle, MD, Departamento de Endocrinología del Hospital Universitario "José E. González"

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

January 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2008

Last Update Submitted That Met QC Criteria

August 18, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endo02

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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