The Effect of Folic Acid Administration in the Progression of Microalbuminuria
Primary Purpose
Diabetic Nephropathies, Hyperhomocysteinemia
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Folic acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Diabetic nephropathies, Hyperhomocysteinemia, Folic acid, Endothelial dysfunction
Eligibility 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
Sites / Locations
- Hospital Universitario "José E. González"
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Administration of an oral placebo pill
Administration of oral folic acid
Outcomes
Primary Outcome Measures
Change in albumin excretion rate
Secondary Outcome Measures
Change in serum homocysteine, thrombomodulin and von Willebrand factor.
Full Information
NCT ID
NCT00737126
First Posted
August 15, 2008
Last Updated
August 18, 2008
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Laboratorios Valdecasas S.A.
1. Study Identification
Unique Protocol Identification Number
NCT00737126
Brief Title
The Effect of Folic Acid Administration in the Progression of Microalbuminuria
Official Title
Folic Acid Administration Reduces the Progression of Microalbuminuria
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Laboratorios Valdecasas S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies, Hyperhomocysteinemia
Keywords
Diabetic nephropathies, Hyperhomocysteinemia, Folic acid, Endothelial dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Administration of an oral placebo pill
Arm Title
2
Arm Type
Experimental
Arm Description
Administration of oral folic acid
Intervention Type
Drug
Intervention Name(s)
Folic acid
Intervention Description
Administration of a daily tablet containing 5 mg of folic acid for 4 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of an oral placebo pill
Primary Outcome Measure Information:
Title
Change in albumin excretion rate
Time Frame
Four months
Secondary Outcome Measure Information:
Title
Change in serum homocysteine, thrombomodulin and von Willebrand factor.
Time Frame
Four months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando J Lavalle, MD
Organizational Affiliation
Departamento de Endocrinología del Hospital Universitario "José E. González"
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario "José E. González"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
The Effect of Folic Acid Administration in the Progression of Microalbuminuria
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