Isotretinoin has been used for the treatment of acne. Some previous studies reported elevated homocystein levels after treatment with isotretinoin. Vitamin B12 and folic acid involved in the metabolism of homocystein.
We have designed this study with the aim of demonstrating if starting folic acid and Vit B12 replacement therapies with isotretinion could be useful for preventing hyperhomocysteinemia and possibly related disorders.
A total of 56 acne patients over the age of 18 years will be included.They will be allocated randomly in to two groups. One group will receive isotretinoin alone and another group will receive folic acid and Vit B12 in combination with isotretinoin. Serum levels of homocystein, folic acid and Vit B12 will be evaluated and compared in both group before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081018607N1
Registration date:2015-06-29, 1394/04/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Maryam Ghiasi
Name of organization / entity
Tehran University of Medical Sciences, Department of Dermatology, Razi Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
mghiasi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
This project will be supported by Tehran University of Medical Siences financially.
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of isotretinoin on the serum level of homocystein with and without folic acid and vit B12 intake
Public title
Evaluation of the effect of isotretinoin on the serum level of homocystein with and without folic acid and vit B12 intake
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Acne patients over 18 years of age who have indication of isotretinoin therapy
Exlusion criteria: pregnancy; lactation; hyperlipidemia; liver failure; renal failure; diadetes mellitus; hypertension; thyroid dysfunction; psoriasis; Behcet disease; intake of antibiotics of cyclin group; smoking; alcohol use; genetic disorders of aminoacids metabolism; multivitamin or folic acid or vit B12 intake
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods St
City
Tehran
Postal code
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
94-01-30-27258-152453
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
serum homocysteine level
Timepoint
before and 2 months after treatment
Method of measurement
measurement in laboratory
Secondary outcomes
1
Description
serum vitamin B12 level
Timepoint
before and 2 months after treatment
Method of measurement
measurement in laboratory
2
Description
serum folic acid level
Timepoint
Before and 2 months after treatment
Method of measurement
Measurement in laboratory
Intervention groups
1
Description
Intervention group:
Vitamin B12, Amp 1 gram, intramuscular injection,once a month for 2 months
Category
Treatment - Drugs
2
Description
Intervention group:
Folic acid, Tab 1 miligram,oral, once a day for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Maryam Ghiasi
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Ghods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences, Departement of Dermatology
Full name of responsible person
Maryam Ghiasi
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5561 8989
Fax
Email
mghiasi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Department of Dermatology
Full name of responsible person
Maryam Ghiasi
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5561 8989
Fax
Email
mghiasi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences, Department of Dermatology
Full name of responsible person
Maryam Ghiasi
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5561 8989
Fax
Email
mghiasi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)