Protocol summary
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Study aim
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Determining the effects of curcumin on GDF15 gene expression and iron status in patients with beta-thalassemia intermedia
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Design
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A clinical trial with two groups of treatment and placebo, double-blind, randomized, phase 2-3 on 30 patients with beta-thalassemia intermedia, was selected to randomized by simple randomisation method (using a card).
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Settings and conduct
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patients will be divided into two groups of treatment and placebo. In this study, which will be performed double blind, physicians and patients are not aware of the distribution and taking medication or placebo. The sampling place will be Imam Reza Clinic in Shiraz. At first, 5 cc of blood is taken from the patients and after a three-month period of taking the drug or placebo, the patients will be sampled again.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: insensitivity to turmeric compounds, male gender, confirmation of beta-thalassemia intermedia by the relevant physician.
Exclusion criteria: diabetes, cardiovascular disease, gallbladder remove.
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Intervention groups
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The treatment group took 500 mg of curcumin at a dose of 1,500 mg for three months under the supervision of a physician.
The placebo group also receives the same amount of placebo in the form of 500 mg capsules with the same dose and shape of the treatment group.
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Main outcome variables
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Serum levels of iron, C-Reactive Protein and ferritin
General information
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Reason for update
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A sampling of patients was after receiving the code of ethics but before receiving the code of intervention.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190902044668N1
Registration date:
2020-08-10, 1399/05/20
Registration timing:
retrospective
Last update:
2020-09-22, 1399/07/01
Update count:
1
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Registration date
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2020-08-10, 1399/05/20
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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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Expected recruitment start date
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2020-04-19, 1399/01/31
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Expected recruitment end date
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2020-07-18, 1399/04/28
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Actual recruitment start date
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2020-04-19, 1399/01/31
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Actual recruitment end date
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2020-07-18, 1399/04/28
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Trial completion date
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2020-07-18, 1399/04/28
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Scientific title
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Evaluation of the effects of curcumin on GDF15 gene expression and iron status in patients with beta-thalassemia intermedia
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Public title
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effects of curcumin on beta-thalassemia intermedia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
gender male
Lack of sensitivity to turmeric compounds
The beta-thalassemia intermedia is approved by the doctor.
Exclusion criteria:
Cardiovascular disease
Diabetes
Gallbladder removal
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Age
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From 18 years old to 35 years old
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Gender
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Male
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Blood sampling in two stages before and after treatment at a rate of 5 cc
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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15 cards with the intervention group code label and 15 cards with the placebo group code label were placed inside the sealed envelopes and each patient was asked to choose randomly one of these envelopes.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The drugs were distributed to patients in unlabeled sealed paper bags.
The main drug and the placebo drug are both taken from the pharmaceutical company, which are similar in shape, size, and color. The difference between the main drug and the placebo was not clear to the participants, The project manager will know the arrangement of the main drug and placebo.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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no
Ethics committees
1
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Ethics committee
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Approval date
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2020-04-19, 1399/01/31
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Ethics committee reference number
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IR.SUMS.REC.1399.124
Health conditions studied
1
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Description of health condition studied
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Intermediate beta-thalassemia
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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 thalassemia
Primary outcomes
1
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Description
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Serum iron
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Timepoint
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At the beginning of the study (before the intervention) and three months after the start of curcumin intake
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Method of measurement
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Atomic absorption spectrometry، ELISA kit
Secondary outcomes
1
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Description
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Serum ferritin concentrations
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Timepoint
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At the beginning of the study (before the intervention) and three months after the start of curcumin intake
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Method of measurement
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ELISA
2
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Description
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C-reactive protein (CRP)
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Timepoint
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At the beginning of the study (before the intervention) and three months after the start of curcumin intake
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group: Curcumin; Each dose contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized based on 5.47 mg of curcumin. three months; Three doses per day orally; Dineh Pharmaceutical Company, Iran.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo; Each dose contains 500 mg of starch or flour. three months; Three doses per orally; Dineh Iran Pharmaceutical Company.
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Category
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Placebo
1
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Sponsor
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Grant name
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no
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Grant code / Reference number
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ندارد
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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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Shiraz 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available