Protocol summary
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Study aim
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Evaluation the effects of alpha lipoic acid on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major.
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Design
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Clinical trials with control group, crossover, double-blinded, randomized
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Settings and conduct
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In this double-blind clinical trial, patients with β-thalassemia major who are referred to Mohammad Kermanshahi Hospital are selected according to inclusion criteria and approved by the physician.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include ages over 15 years old and exit criteria including the history of hepatitis B and C, heart failure and renal failure, cancer, allergies, drug-induced disordered digestive problems, pregnancy, smoking, The use of shlaturi except desphonac and following a particular diet.
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Intervention groups
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At the beginning of the intervention, half of the patients will receive the alpha-lipoic acid (supplement group) and patients will be asked to take a 600 mg capsule of alpha-lipoic acid for 8 weeks each day in addition to their chelator. The other half of the patients take placebo which is apparently similar to the alpha-lipoic acid (the placebo group), these patients also receive a placebo for 8 weeks in addition to their chelator. In order to eliminate the complementary and placebo interaction, the duration of washout is considered for 3 weeks, and when it passes, the next stage of the clinical trial will begin with a crossover. In the second intervention period, the two groups will be displaced.
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Main outcome variables
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Total antioxidant capacity, Malondialdehyde, Serum Iron, Ferritin, Transferrin, homocysteine (HCY), Lipoprotein-associated phospholipase A2 (Lp-PLA2), Trimethylamine N-oxide (TMAO), Osteoprotegerin (OPG)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017061714237N2
Registration date:
2017-08-15, 1396/05/24
Registration timing:
prospective
Last update:
2018-07-05, 1397/04/14
Update count:
1
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Registration date
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2017-08-15, 1396/05/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Kermanshah University of Medical Sciences
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Expected recruitment start date
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2017-09-23, 1396/07/01
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Expected recruitment end date
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2018-03-21, 1397/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effects of alpha lipoic acid or placebo on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major.
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Public title
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Effects of alpha lipoic acid on β- Thalassemia Major
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 15 years
Exclusion criteria:
History of hepatitis B and C
heart failure and kidney failure
cancer
allergies
digestive problems disrupting drug intake
pregnancy
smoking
The use of shlaturi except Desphonac
following a particular diet
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Age
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From 15 years old to 30 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done using randomized block design method.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, none of the subjects and researchers do not know who is in what group.
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-06-14, 1396/03/24
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Ethics committee reference number
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KUMS.REC.1396.144
Health conditions studied
1
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Description of health condition studied
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β-thalassemia Major
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ICD-10 code
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D56.1
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ICD-10 code description
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Beta thalassaemia
Primary outcomes
1
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Description
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Total antioxidant capacity
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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nmol/ml, ELIZA
2
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Description
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Malondialdehyde
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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nm/ml, Tiobarbitoric acid
3
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Description
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Serum Iron
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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μmol/ml, photometric
4
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Description
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Ferritin
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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ngram/ml, ELIAZ
5
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Description
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Transferrin
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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μgram/ml, ELIZA
6
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Description
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homocysteine (HCY)
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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μmol/L, ELIZA
7
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Description
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Lipoprotein-associated phospholipase A2 (Lp-PLA2)
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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nmol/mL, ELIZA
8
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Description
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Trimethylamine N-oxide (TMAO)
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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μmol/L, ELIZA
9
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Description
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Osteoprotegerin (OPG)
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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mg/dl, ELIZA
Secondary outcomes
1
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Description
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Serum Triacylglyceride
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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mg/dl, Enzymatic
2
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Description
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Serum Cholesterol
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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mg/dl, Enzymatic
3
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Description
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HDL-c
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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mg/dl, Direct Enzymatic
4
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Description
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LDL-c
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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mg/dl, FriedWald Formula
5
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Description
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Body Weight
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Timepoint
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Week 0, Week 8, Week 11, Week 19
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Method of measurement
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Scale, Kilogram
Intervention groups
1
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Description
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Intervention group: 600 mg alpha lipoic acid (C8H14O2S2) capsules once a day for 8 weeks. Product of Support Nutrition company, USA.
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Category
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Treatment - Other
2
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Description
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Control group: 600 mg placebo capsules (corn flour ) similar to alpha lipoic acid in shape and color once a day for 8 weeks
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All data is unobtrusive when unrecognizable
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When the data will become available and for how long
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Start the access period after printing the results
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To whom data/document is available
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All people have permission to access
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Under which criteria data/document could be used
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In case of confidentiality of data
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From where data/document is obtainable
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hadi_nut@yahoo.com
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What processes are involved for a request to access data/document
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By submitting a request to the researcher, the relevant request will be reviewed.
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Comments
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