Protocol summary

Summary
This study is a randomized double-blind placebo controlled trial in 64 patients with beta thalassemia major. The objective of the study is to determine the effects of curcumin supplementation on iron overload, oxidative stress and insulin resistance in patients with beta thalassemia major. The inclusion criteria is: age between 18 and 40, consumption of deferoxamine as an iron chelator drug, patients without hepatitis B, C and HIV, Not taking any nutritional supplements from 3 months before the start of the study and the exclusion criteria is: A significant change in dose of deferoxamine therapy during the study and pregnancy. A general questionnaire and 3-day, 24-hour dietary recalls will be completed for each subject at the beginning of the study. After matching according to sex and age the subjects will be randomly assigned to intervention and placebo group. Fasting blood sample ( 5 cc) will be obtained from each patient at the beginning of the study for measuring parameters such as serum iron, hemoglobin, ferritin, hepcidin, Non-transferrin-bound Iron, malondialdehyde, serum total antioxidant capacity,catalase, glucose and insulin. Then Patients in intervention group will take 2 curcumin capsules per day (each containing 500 mg curcuminoids) for 12 weeks and patients in placebo group will take 2 placebo capsules daily for 12 weeks. Patients and researchers will keep blind during the study. At the end of the study food intake will be evaluated again and blood sampling will be obtained again for measuring biochemical parameters

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016053028165N1
Registration date: 2016-06-30, 1395/04/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-30, 1395/04/10
Registrant information
Name
Esmat Nasseri
Name of organization / entity
National Nutrition and Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7486
Email address
esm_nasseri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition And Food Technology Research Institute, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of curcumin supplementation on iron overload, oxidative stress and insulin resistance in patients with beta thalassemia major
Public title
Effect of curcumin supplement in patients with beta thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 40, Regular blood transfusions based on prescription, consumption of deferoxamine as an iron chelator drug, Not taking any nutritional supplements from 3 months before the start of the study, patients without hepatitis B, C, HIV and chronic kidney and heart diseases, not using other chelator medication except deferoxamine. Excluson criteria: A significant change in dose of deferoxamine therapy during the study, using another iron chelator drug in addition to deferoxamine and pregnancy
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of National Nutrition and Food Technology Research Institute
Street address
No.7, West Arghavan Ave.,Farahzadi Blvd.,Qods Town, Tehran
City
Tehran
Postal code
1981619573
Approval date
2015-10-19, 1394/07/27
Ethics committee reference number
IR.SBMU.nnftn.Rec.1394.18

Health conditions studied

1

Description of health condition studied
Beta thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
Hemoglobin
Timepoint
Before the study and after the study
Method of measurement
Cyanmethemoglobin method

2

Description
Serum iron
Timepoint
Before the study and after the study
Method of measurement
Spectrophotometry

3

Description
Ferritin
Timepoint
Before the study and after the study
Method of measurement
Elisa

4

Description
Hepcidin
Timepoint
Before the study and after the study
Method of measurement
Elisa

5

Description
Non-transferrin-bound iron
Timepoint
Before the study and after the study
Method of measurement
HPLC

6

Description
Malondialdehyde
Timepoint
Before the study and after the study
Method of measurement
Spectrophotometry

7

Description
Serum total antioxidant capacity
Timepoint
Before the study and after the study
Method of measurement
FRAP

8

Description
Catalase
Timepoint
Before the study and after the study
Method of measurement
Spectrophotometry

9

Description
Glucose
Timepoint
Before the study and after the study
Method of measurement
Enzymatic method

10

Description
Insulin
Timepoint
Before the study and after the study
Method of measurement
Elisa

11

Description
Insulin resistance
Timepoint
Before the study and after the study
Method of measurement
Calculation by using formula

Secondary outcomes

1

Description
Weight
Timepoint
before the study and after the study
Method of measurement
Scale

2

Description
Body mass index (BMI)
Timepoint
Before the study and after the study
Method of measurement
Calculation by using formula

Intervention groups

1

Description
Intervention group will take 2 curcumin capsules per day (each containing 500 mg curcuminoids) for 12 weeks
Category
Treatment - Drugs

2

Description
Control group will take 2 placebo capsules daily for 12 weeks. Placebo capsules are similar in size and color to the curcumin capsules
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkola Thalassemia Center
Full name of responsible person
Mina Abdollahzadeh
Street address
Amirkola Thalassemia Center, Amirkola, Babol, Mazandaran
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Morteza Abdollahi
Street address
No.7,West Arghavan Ave.,Farahzadi Blvd.,Qods Town,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
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
National Nutrition and Food Technology Research Institute
Full name of responsible person
Elahe Mohammadi
Position
PhD Candidate in Nutrition
Other areas of specialty/work
Street address
No.7, West Arghavan Ave.,Farahzadi Blvd.,Qods Town, Tehran
City
Tehran
Postal code
Phone
+98 21 2235 7486
Fax
Email
E.mohamadi52@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Esmat Naseeri
Position
PhD in Nutrition
Other areas of specialty/work
Street address
No.7, West Arghavan Ave.,Farahzadi Blvd.,Qods Town, Tehran
City
Tehran
Postal code
Phone
+98 21223574836
Fax
Email
nasseri_esm@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Elahe Mohammadi
Position
PhD Candidate in Nutrition
Other areas of specialty/work
Street address
No.7, West Arghavan Ave.,Farahzadi Blvd.,Qods Town, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
e.mohamadi52@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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