1. Home
  2. Approved trials
  3. » فارسی

Effect of Folate Supplementations and their Relationship with Methyl Tetra Hydrofolate Reductase Folic Acid Polymorphisms on Metabolic, Inflammatory Indices and Nerve Conduction Velocity Variations in Patients with Diabetic Polyneuropathy

Protocol summary

Study aim
Effect of Folate Supplementations and their Relationship with Methyl Tetra Hydrofolate Reductase Folic Acid Polymorphisms on Metabolic, Inflammatory Indices and Nerve Conduction Velocity Variations in Patients with Diabetic Polyneuropathy
Design
In this research, 80 eligible patients with diabetic polyneuropathy were chosen and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
The present study is a triple-blind randomized clinical trial study and participants, researcher, and statistical analyser will not know from assigned intervention.The population includes patients with diabetic neuropathy referring to Ilmum Musasadr Clinic in Isfahan. The number of participants will include 80 patients and the subjects will be divided into two groups .Patients in the intervention and control group will receive 1 mg per day folic acid or placebo for two months. After diagnosis of diabetic neuropathy by neurologist will examine the polymorphisms of MTHFR gene including C677T and A1298C. At the first and end study plasma folic acid , metabolic indices, C-reactive protein inflammatory marker and nerve conduction velocity variations will be examined.
Participants/Inclusion and exclusion criteria
Patients with diabetic polyneuropathy, >20 years old, diabetic neuropathy approved by the neurologist by the EMG-NCV, the desire to participate in the study, the desire to consume folic acid within 8 weeks؛ non-diabetic neuropathic patients, pregnant or planning pregnant women, alcohol users, smoking, multivitamin-containing minerals containing folic acid, B12 and B6consumers during the study, drugs such as methotrexate, bacterium, antiepileptic and sulfa antibiotics
Intervention groups
The patients with diabetic polyneuropathy in the treatment group will receive folic acid supplements for 8- weeks and patients in the other group also will receive the placebo tablets.
Main outcome variables
Metabolic, inflammatory and nerve conduction velocity variations

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N22
Registration date: 2018-01-08, 1396/10/18
Registration timing: retrospective

Last update: 2018-01-08, 1396/10/18
Update count: 0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Folate Supplementations and their Relationship with Methyl Tetra Hydrofolate Reductase Folic Acid Polymorphisms on Metabolic, Inflammatory Indices and Nerve Conduction Velocity Variations in Patients with Diabetic Polyneuropathy
Public title
Effect of Folic Acid Supplementation among Diabetic Polyneuropathy Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
>20 Years Old Diabetic Neuropathy Approved by the Neurologist Desire to Consume Folic Acid during 8 Weeks
Exclusion criteria:
Non-Diabetic Neuropathic Patients Pregnant Women Alcohol Users Smoking Multivitamin-minerals Containing Folic Acid, B12 and B6 Consumers during Study Drugs Consumers that may Interfere with the Absorption Folic Acid such as methotrexate, bacterium, antiepileptic and sulfa antibiotics
Age
From 20 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In present study, simple randomization method will be used. The randomization unit is individually and we will use the random number table method for random sequences. A random numbered table is a collection of numbers that are without a specific pattern, completely random and as table. The next step is allocation concealment and will use sequentially numbered, sealed, opaque envelopes. Then, based on the sample size, number of envelopes with aluminum surface are provided and each random sequence created on a card and the cards are inserted into the envelopes, respectively. At the time of registration for the participants, according to eligible participants, one of the envelopes is opened and the allocated group for participants is revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is a triple blind method and participants, researcher, and statistical analyser will not know according to assigned intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of Medical Sciences
Street address
Hezar Jirib Street, Isfahan, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-03-10, 1395/12/20
Ethics committee reference number
IR.MUI.REC.1395.2.285

Health conditions studied

1

Description of health condition studied
Diabetic Polyneuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy

Primary outcomes

1

Description
Nerve Conduction Velocity
Timepoint
week 0 and week 8
Method of measurement
EMG-NCV

2

Description
serum folic acid
Timepoint
week 0 and week 8
Method of measurement
Laboratory analysis (blood test)

3

Description
serum vitamin B12
Timepoint
week 0 and week 8
Method of measurement
Laboratory analysis (blood test)

4

Description
Serum homocystein
Timepoint
week 0 and week 8
Method of measurement
Laboratory analysis (blood test)

Secondary outcomes

1

Description
CRP
Timepoint
Week 0 and week 8
Method of measurement
Laboratory analysis (blood test)

2

Description
HbA1C
Timepoint
Week 0 and week 8
Method of measurement
Laboratory analysis (blood test)

Intervention groups

1

Description
Intervention group: Folic acid supplement, tablet 1 mg/day, 8- weeks, Maad pharmacy company
Category
Treatment - Drugs

2

Description
Control group:placebo, 1 mg/day, 8- weeks, School of Pharmacy Isfahan university of medical sciences.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Mousa Sadr Clinic
Full name of responsible person
Tayebeh Mottaghi
Street address
Shohada Square, Forughi Ave, Imum Mousa Sadr Clinic
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Amir mansour alavi
Street address
Hezar Jarib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Email
am.alavi@nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Tayebeh Mottaghi
Position
PhD Student of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Streetو Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Fax
Email
tmottaghi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Askari
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib streetو Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Fax
Email
askari@mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tayebeh Mottgahi
Position
PhD Student of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjirib Strreet, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Fax
Email
tmottaghi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...