Objective: Evaluation the effects of alpha lipoic acid on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major. Design: cross-over clinical trial. Setting and conduct: After signing a written informed consent, All participants will be randomly assigned to alpha lipoic acid and placebo each for 8 weeks. After 3 weeks washout period, the second phase will be started. Then the participants will be crossed over to the alternate group for additional 8 weeks. To assess the compliance of the participants, every two week a 3 day dietary record and a 3 day physical activity record will be taken. Anthropometric measurements and biochemical assessments will be measured at the beginning and end of each phases.Major inclusion criteria: Patient with β- Thalassemia Major.
Major exclusion criteria: Use of chelator other than Deferoxamine, antioxidant supplement and anti inflammatory drugs consumption. Intervention: Patient in the alpha lipoic acid group were asked to daily intake a 600 mg alpha lipoic acid capsule for 8 weeks. Main outcome measures: serum triglyceride (TG), total-cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein cholesterol (HDL-c ), Malondialdehyde ( MDA), Total Antioxidant Capacity (TAC), Ferritin, Serum Iron, Transferrin Iron Binding Capacity (TIBC), Complete Blood count ( CBC).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061714237N2
Registration date:2017-08-15, 1396/05/24
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Elham Sharifi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1730 6006
Email address
elham_sharifi@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of alpha lipoic acid or placebo on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major.
Public title
Effects of alpha lipoic acid on β- Thalassemia Major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were; patient with β-thalassemia major at age range of 15-30 years old; ferritin >1000 μg/L during last 6 month.
Exclusion criteria were; history of hepatitis B and C; heart failure; kidney failure; cancer; allergy; gastrointestinal disorder interfering with drug absorption; pregnancy; smoking; use of chelator other than Deferoxamine; antioxidant supplement and anti inflammatory drug consumption; adherence to a specific diet.
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Randomization will be done using randomized block design method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd- Kermanshah
City
Kermanshah
Postal code
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
KUMS.REC.1396.144
Health conditions studied
1
Description of health condition studied
β-thalassemia Major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
nmol/ml, ELIZA
2
Description
Malondialdehyde
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
nm/ml, Tiobarbitoric acid
3
Description
Serum Iron
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
μmol/ml, photometric
4
Description
Ferritin
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
ngram/ml, ELIAZ
5
Description
Transferrin
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
μgram/ml, ELIZA
Secondary outcomes
1
Description
Serum Triacylglyceride
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, Enzymatic
2
Description
Serum Cholesterol
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, Enzymatic
3
Description
HDL-c
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, Direct Enzymatic
4
Description
LDL-c
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, FriedWald Formula
5
Description
Body Weight
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
Scale, Kilogram
Intervention groups
1
Description
Intervention group: 600 mg alpha lipoic acid (C8H14O2S2) capsules once a day for 8 weeks. Product of Support Nutrition company, USA.
Category
Treatment - Other
2
Description
Control group: 600 mg placebo capsules (corn flour ) similar to alpha lipoic acid in shape and color once a day for 8 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Elham Sharifi Zahabi
Street address
Mohammad Kermanshahi Hospital, Mosavari Avenue, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University Of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Deputy of Research and Technology- Kermanshah University Of Medical Sciences- Shahid Beheshti Blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
School of Nutrition and Food Sciences-Kermanshah University of Medical Sciences
Full name of responsible person
Hadi Abdollahzad
Position
Assistant Professor/ PhD
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Square-Kermanshah
City
School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Squre-Kermanshah
Postal code
Phone
+98 83 3826 2052
Fax
Email
Hadi_Nut@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nutrtion and Food Sciences- Kermanshah University of Medical Sciences
Full name of responsible person
Hadi Abdollahzad
Position
Assistant Professor/ PhD
Other areas of specialty/work
Street address
School of Nutrtion and Food Sciences- Next to Farabi Hospital- Isar Square-Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3826 2052
Fax
Email
hadi_nut@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam khomeini Comprehensive Health center
Full name of responsible person
Elham Sharifi Zahabi
Position
MSc
Other areas of specialty/work
Street address
Imam khomeini Town- Kermanshah
City
Kermanshah
Postal code
Iran
Phone
00
Fax
Email
elham_sharifi@nutr.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)