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The effect of supplementation with Nigella Sativa on serum Nesfatin-1, vascular endothelial growth factor (VEGF) and insulin resistance in patients with Hashimoto in comparison of placebo treated group

Protocol summary

Summary
In the current randomized double blind placebo controlled trial, 40 patients with hashimoto thyroiditis are enrolled. Patients are divided into two intervention and placebo groups with random permuted block and are matched according to age, gender and drug dosage. After signing written informed consent anthropometric parameters including weight, height and BMI will be measured and subjects in intervention and control group will receive 1 gram/day packages of Nigella Sativa or placebo for four weeks. The study's inclusion criteria are as follows: aged between 20-50 years old, diagnosis of Hashimoto thyroiditis by physician, completing written informed consent. Exclusion criteria are: pregnancy, lactation, taking supplements such as vitamin E, C, zinc, folate, cobalamin and phytoestrogens in past three months, any history of celiac, cardiovascular disease, arthritis, autoimmune and inflammatory disease, thyroid abnormalities and surgeries, and being on any special diets.

General information

Acronym
--
IRCT registration information
IRCT registration number: IRCT2015021719082N4
Registration date: 2015-03-15, 1393/12/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Mahdieh Abbasalizad Farhangi
Name of organization / entity
Department of Community Nutrition School of Nutrition
Country
Iran (Islamic Republic of)
Phone
+98 413357580
Email address
abbasalizadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-27, 1393/10/06
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of supplementation with Nigella Sativa on serum Nesfatin-1, vascular endothelial growth factor (VEGF) and insulin resistance in patients with Hashimoto in comparison of placebo treated group
Public title
The effect of Nigella Sativa on treatment of Hashimoto thyroiditis
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: aged between 20-50 years old; physician diagnosis of hashimoto thyroiditis; completeing written informed consent) (Exclusion criteria: pregnancy, lactation, taking supplements such as vitamin E, C, zinc, folate, cobalamin and phytoesterogens in past three months;any history of celiac, cardiovascular disease, arthritis, autoimmune and inflammatory disease; thyroid abnormalities and surgeries and being on diet)
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Undersecretary of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
516614711
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
93173

Health conditions studied

1

Description of health condition studied
Hashimoto Thyroiditis
ICD-10 code
E06.3
ICD-10 code description
Autoimmune Thyroiditis

Primary outcomes

1

Description
Nesfatin-1
Timepoint
before and 4 weeks after intervention
Method of measurement
ELIZA method

2

Description
Vascular Endotheilal Growth Factor (VEGF)
Timepoint
Before and 4 weeks After Intervention
Method of measurement
ELIZA method

Secondary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Before and Four Weeks After Intervention
Method of measurement
Enzymatic Method

2

Description
Insulin Resistance
Timepoint
Before and Four Weeks After Intervention
Method of measurement
HOMA-IR

Intervention groups

1

Description
Placebo: 1 gram per day starch as placebo for four weeks treatment period
Category
Treatment - Drugs

2

Description
Supplement: one gram per day Nigella Sativa for four weeks treatment period
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition Research Center
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Street address
Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Undersecretary of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad-Reza Rashidi
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Undersecretary of Tabriz 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
Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Position
Assistant Professor (Ph.D.)
Other areas of specialty/work
Street address
Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
abbasalizad_m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Commnity Nutrition, Faculty of Nutrition, Tabriz University of Medical Scineces
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Position
Assistant Professor, (Ph.D.)
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Faculty of Nutrition
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
abbasalizad_m@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Position
Assistant Professor- Ph.D.
Other areas of specialty/work
Street address
Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
Web page address

Sharing plan

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