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The Effect of Folic Acid Administration in the Progression of Microalbuminuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737126
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : August 19, 2008
Laboratorios Valdecasas S.A.
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

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.

Primary Outcome Measures :
  1. Change in albumin excretion rate [ Time Frame: Four months ]

Secondary Outcome Measures :
  1. Change in serum homocysteine, thrombomodulin and von Willebrand factor. [ Time Frame: Four months. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737126

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Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Laboratorios Valdecasas S.A.
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Study Chair: Fernando J Lavalle, MD Departamento de Endocrinología del Hospital Universitario "José E. González"
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Responsible Party: Jesús Zacarías Villarreal Pérez, Departamento de Endocrinologia Identifier: NCT00737126    
Other Study ID Numbers: Endo02
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: August 19, 2008
Last Verified: August 2008
Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Diabetic nephropathies
Folic acid
Endothelial dysfunction
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Deficiency Diseases
Nutrition Disorders
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs