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The Effect of Folic Acid Administration in the Progression of Microalbuminuria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737126
First Posted: August 18, 2008
Last Update Posted: August 19, 2008
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.
Collaborator:
Laboratorios Valdecasas S.A.
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez
  Purpose

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 Intervention
Diabetic Nephropathies Hyperhomocysteinemia Drug: Folic acid Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Folic Acid Administration Reduces the Progression of Microalbuminuria

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

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

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

Enrollment: 40
Study Start Date: January 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00737126


Locations
Mexico
Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Laboratorios Valdecasas S.A.
Investigators
Study Chair: Fernando J Lavalle, MD Departamento de Endocrinología del Hospital Universitario "José E. González"
  More Information

Responsible Party: Jesús Zacarías Villarreal Pérez, Departamento de Endocrinologia
ClinicalTrials.gov Identifier: NCT00737126     History of Changes
Other Study ID Numbers: Endo02
First Submitted: August 15, 2008
First Posted: August 18, 2008
Last Update Posted: August 19, 2008
Last Verified: August 2008

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Diabetic nephropathies
Hyperhomocysteinemia
Folic acid
Endothelial dysfunction

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Hyperhomocysteinemia
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
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs