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Effect of vitamin K1 supplementation on some biochemical markers and clinical status in women with rheumatoid arthritis

Protocol summary

Summary
The aim of this study is to evaluate the effect of vitamin K1 supplementation on some biochemical markers and clinical status in women with rheumatoid arthritis. 64 women with RA who are 20-50 years old and meet the inclusion criteria would be recruited from clinics of Tabriz University of medical sciences. The patients are assigned as a double blind manner into placebo or intervention groups based on age and severity of disease. The intervention group receives oral vitamin K1 supplement one tablet for 60 days (10 mg vitamin K1/tablet) and the placebo group receive placebo in the same way. Serum hsCRP, ,IL-6, TNFa, MMP-3, RF,TC,TG,HDL are measured at baseline and after intervention in 2 groups. Also, BMI, waist and hip circumference, dietary habits, physical activity and anxiety state are evaluated.

General information

Acronym
RA
IRCT registration information
IRCT registration number: IRCT201205203140N4
Registration date: 2012-07-29, 1391/05/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-29, 1391/05/08
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Student Research Committee, Vice Chancellor for Research, Nutrition and Health Faculty, Tabriz University of Medical Sciences
Expected recruitment start date
2012-07-20, 1391/04/30
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of vitamin K1 supplementation on some biochemical markers and clinical status in women with rheumatoid arthritis
Public title
Effect of vitamin K1 supplementation in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female rheumatoid arthritis patients who have ACR criteria 1987 for RA, age 20-50 years old; not changing the treatment protocol since 2 months prior to the study; mild to moderate disease severity. Exclusion criteria: pregnancy; lactation; postmenopausal state; receiving hormone replacement therapy; smoking or exposure to passive smoking; receiving antioxidant or anti-inflammatory supplements since 1 month prior to the study; Presence of cancer, diabetes mellitus, hormonal dysfunctions, undernutrition, severe obesity (BMI>40), uncontrolled hypertension, renal and hepatic diseases, digestion disorders, changing treatment and lifestyle, PT abnormality.
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
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 Tabriz university of medical sciences
Street address
Research Vice-chancellor, central building, number 2, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2012-05-08, 1391/02/19
Ethics committee reference number
5/4/1683

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified

Primary outcomes

1

Description
Clinical Outcomes
Timepoint
before and after intervention (60 days)
Method of measurement
by means of DAS-28 validated questionnaire

2

Description
serum levels of IL-6, hsCRP, TNFa
Timepoint
before and after intervention (60 days)
Method of measurement
by means of special kits in Tabriz Pharmaceutical Research Center

3

Description
serum level of RF (Rheumatoid Factor)
Timepoint
before and after intervention (60 days)
Method of measurement
by means of special kit in Tabriz Pharmaceutical Research Center

4

Description
Lipid profile (TC,TG,HDL,LDL)
Timepoint
before and after intervention (60 days)
Method of measurement
all parameters as HDL-C- Total cholesterol- triglyceride with enzymatic kits except LDL-c ( by means of Friedwald formula)

5

Description
Serum level of matrix metalloproteinases-3 (MMP-3)
Timepoint
before and after intervention (60 days)
Method of measurement
by means of special kit in Tabriz Pharmaceutical Research Center

Secondary outcomes

1

Description
Dietary Intake of Energy, Nutrients and Comparison with RDA
Timepoint
before and after intervention (60 days)
Method of measurement
dietary record for 3 days

2

Description
anthropometric indicator (BMI)
Timepoint
before and after intervention (60 days)
Method of measurement
Body weight without shoes with calibrated scale, Standing height without shoes are measuredl. BMI was calculated with this equation: W(kg) /H(m)2

Intervention groups

1

Description
intervantion group: 10 mg vitamin K1 every day for 60 days - after a meal - chewable tablet
Category
Treatment - Drugs

2

Description
control group: placebo every day for 60 days- chewable tablet -after a meal
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golgasht clinic
Full name of responsible person
Dr. Susan Kolahi
Street address
Azadi avenue, close to Golgasht avenue, Golgasht clinic-Third Floor
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Nutrition and Health Faculty in Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi, Dr Ostadrahimi
Street address
Health and nutrition school, Attar Neishabouri Avenue, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Nutrition and Health Faculty in 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
Health and Nutrition Faculty, Tabriz University of medical sciences
Full name of responsible person
Dr. Bahram Pourghassem Gargari
Position
PHD of nutritional biochemistry, Associate Professor of Nutrition and Health Faculty
Other areas of specialty/work
Street address
Health & Nutrition Faculty, Tabriz university of medical sciences, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pourghassemb@tbzmed.ac.ir ; bahrampg@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health and nutrition faculty, Tabriz university of medical sciences
Full name of responsible person
Dr. Bahram Pourghassem Gargari
Position
PHD of nutritional biochemistry, Associate Professor of Nutrition and Health Faculty
Other areas of specialty/work
Street address
Health and Nutrition Faculty, Tabriz University of medical sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pourghassemb@tbzmed.ac.ir ; bahrampg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health and Nutrition Faculty, Tabriz university of medical sciences
Full name of responsible person
Neda Ghamarzad Shishavan
Position
MS student of nutrition
Other areas of specialty/work
Street address
Health and Nutrition Faculty, Tabriz university of medical sciences- Attar neishaboori Avenue, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1523 9661
Fax
Email
ghamarzad.n@gmail.com ; ghamarzad@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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