The Effect of Folic Acid Administration in the Progression of Microalbuminuria

Diabetic Nephropathies Clinical Trial

Official title:

Folic Acid Administration Reduces the Progression of Microalbuminuria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737126
• Other study ID #: Endo02
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: August 18, 2008
• Start date: January 2004
• Est. completion date: December 2005

Study information

• Verified date: August 2008
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Hyperhomocysteinemia
• Kidney Diseases

Intervention

Drug:
• Folic acid
Administration of a daily tablet containing 5 mg of folic acid for 4 months.
• Placebo
Administration of an oral placebo pill

Locations

Country	Name	City	State
Mexico	Hospital Universitario "José E. González"	Monterrey	Nuevo León

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez	Laboratorios Valdecasas S.A.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in albumin excretion rate		Four months	No
Secondary	Change in serum homocysteine, thrombomodulin and von Willebrand factor.		Four months.	No