The Effect of Folic Acid Administration in the Progression of Microalbuminuria

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez (Other)

Overall Status

Completed

CT.gov ID

NCT00737126

Collaborator

Laboratorios Valdecasas S.A. (Other)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies Hyperhomocysteinemia	Drug: Folic acid Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Folic Acid Administration Reduces the Progression of Microalbuminuria

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in albumin excretion rate [Four months]

Secondary Outcome Measures

Change in serum homocysteine, thrombomodulin and von Willebrand factor. [Four months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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