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The effect of Folic acid supplementation on biochemical and Redox indices in patients with type 2 diabetes

Protocol summary

Summary
To determine the effect of Folic acid supplementation on biochemical and Redox indices in patients with type 2 diabetes, seventy men with type2 diabetes who met the inclusion criteria were included in the study. These patients were recruited from Imam Reza endocrine clinic of Tabriz University of Medical Sciences, Iran. The patients were randomly assigned, in a double blind fashion, to receive placebo or folic acid (5mg/day) for 8weeks, sequentially. Weight, height and blood pressure were measured at the first and the end of study. Fasting venous blood samples were taken before and after treatment for biochemistry and Redox indices, including: fasting blood sugar, lipid profiles, HbA1C, insulin, serum vitamin B12, folic acid, hemocysteine, Serum malondialdehyde (MDA), Total antioxidant capacity (TAC). HOMA-IR are calculated by following formula: fasting insulin (mu/ml)* fasting glucose (mg/dl)/405. Also 3-day food intake 24h recalls were taken from all subjects, at first and during the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811033140N1
Registration date: 2010-03-31, 1389/01/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-03-31, 1389/01/11
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences and Nutrition research committee
Expected recruitment start date
2009-10-18, 1388/07/26
Expected recruitment end date
2010-03-16, 1388/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of Folic acid supplementation on biochemical and Redox indices in patients with type 2 diabetes
Public title
The effect of Folic acid supplementation in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: -having the type 2 diabetes -voluntary consent for participation in the study -use of metformin at least 1500mg/day for >6month. Exclusion criteria: -use of multivitamin-mineral supplements at least 6month before the study -smoking, alcohol abuse -treatment with insulin -having the hepatic, renal failure, cardiovascular, celiac, gastrointestinal, rheumatic, endocrine, thyroid disorders -leukemia -abnormalities in the enzymes that metabolize the hemocysteine –use of corticosteroids, anticonvulsants, isoniazid
Age
From 36 years old to 78 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golbad street
City
Tabriz
Postal code
Approval date
1388-09-05, 769/01/-560
Ethics committee reference number
5/4/6827

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
non-Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Improvement of antioxidant indices
Timepoint
8weeks
Method of measurement
Assessments of changes in MDA and TAC

2

Description
FBS, insulin resistance, HbA1C, creatinine, lipid profiles
Timepoint
8weeks
Method of measurement
laboratory

3

Description
Serum hemocysteine, folic acid and B12
Timepoint
8weeks
Method of measurement
laboratory

Secondary outcomes

1

Description
Blood pressure
Timepoint
8weeks after the supplementation
Method of measurement
Sphygmometer

2

Description
Body Mass Index
Timepoint
8 weeks after the supplementation
Method of measurement
Weight(Kg)/height(m2)

Intervention groups

1

Description
Control group: plasebo
Category
Placebo

2

Description
Interventinal group: 5mg/day of oral folic acid
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza endocrine clinic
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical sciences & Nutrition research committee
Full name of responsible person
Bahram Pourghassem
Street address
Health & Nutrition Faculty
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences & Nutrition research committee
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Health and Nutrition Faculty, Tabriz university of medical sciences
Full name of responsible person
Bahram Pourghassem
Position
PhD
Other areas of specialty/work
Street address
Health and Nutrition Faculty of Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pourghassemb@tbzmed.ac.ir & bahrampg@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Bahram Pourghassem
Position
PhD
Other areas of specialty/work
Street address
Health and Nutrition Faculty of Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pourghassemb@tbzmed.ac.ir & bahrampg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health and Nutrition Faculty
Full name of responsible person
Vahide Aghamohammadi
Position
MS
Other areas of specialty/work
Street address
Health and Nutrition Faculty of Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
v_agamohammadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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