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Completed

NCT Number: NCT00737126

The Effect of Folic Acid Administration in 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.

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Key information

Conditions

Diabetic Nephropathies Amino Acid Metabolism, Inborn Errors Avitaminosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hyperhomocysteinemia Kidney Diseases Malabsorption Syndromes Male Urogenital Diseases Malnutrition Metabolic Diseases Metabolism, Inborn Errors Nutrition Disorders Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario "José E. González"

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Drug

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

Placebo

Drug

Administration of an oral placebo pill

Primary outcomes

  1. Change in albumin excretion rate

    Time frame: Four months

Secondary outcomes

  1. Change in serum homocysteine, thrombomodulin and von Willebrand factor.

    Time frame: Four months.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Collaborators

  • Laboratorios Valdecasas S.A.

Registry information

Official study title

Folic Acid Administration Reduces the Progression of Microalbuminuria

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Aug 18, 2008
Registry last updated
Aug 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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