The Effect of Folic Acid Administration in the Progression of Microalbuminuria

Folic Acid Administration Reduces the Progression of Microalbuminuria

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00737126

Enrollment

Registered

2008-08-18

Start date

2004-01-31

Completion date

2005-12-31

Last updated

2008-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathies, Hyperhomocysteinemia

Keywords

Diabetic nephropathies, Hyperhomocysteinemia, Folic acid, Endothelial dysfunction

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.

Interventions

DRUGFolic acid

Administration of a daily tablet containing 5 mg of folic acid for 4 months.

DRUGPlacebo

Administration of an oral placebo pill

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in albumin excretion rate	Four months

Secondary

Measure	Time frame
Change in serum homocysteine, thrombomodulin and von Willebrand factor.	Four months.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026