Assessing effect of L-carnitine supplementation on nutritional status, serum inflammatory and oxidative stress factors, matrix metalloproteinase enzymes and clinical symptoms of females with knee osteoarthritis
(1)Objectives: Effect of L-carnitine supplementation in comparison with placebo on nutritional status, serum inflammatory and oxidative stress factors, matrix metalloproteinase enzymes and clinical symptoms of females with knee osteoarthritis
(2)Design: Double blind randomized clinical trial
(3)Setting and conduct: 72 volunteer female patients with bilateral primary osteoarthritis of knee who receive the same and standard pharmaucetical treatments, will be randomly divided into two groups intervention (L-carnitine) and control (placebo).
(4)Participants including major eligibility criteria: volunteer female patients with bilateral primary osteoarthritis of knee aged 40-60 years old and body mass index of 25-35; Using glucoseamine & chondrotin sulphate supplements and acetaminophene as anti-pain drug; Patient tendency and ability to participate in the study.
(5)Intervention: Intervention group: 750 mg/day L-carnitine as 3 tablets of 250 mg and control group: placebo as 3 tablets per day for 8 weeks.
(6) Main outcome measures: Clinical symptoms icluding pain, joint stiffness and disability; Nutritional status; Inflammatory factors including hs-CRP & Interleukin-1β(IL-1β); Oxidative factors including malondialdehyde(MDA) & total antioxidant capacity(TAC); Matrix metalloproteinase-1(MMP-1) and Matrix metalloproteinase-13 (MMP-13)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311231197N17
Registration date:2013-11-26, 1392/09/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-26, 1392/09/05
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences - Nutrition Research Center
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing effect of L-carnitine supplementation on nutritional status, serum inflammatory and oxidative stress factors, matrix metalloproteinase enzymes and clinical symptoms of females with knee osteoarthritis
Public title
Assessing effect of L-carnitine supplementation on nutritional status, serum inflammatory and oxidative stress factors, matrix metalloproteinase enzymes and clinical symptoms of females with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Female; Age: 40-60 years; Bilateral primary osteoarthritis of knee (according to ACR classification); Body mass index of 25-35; Using glucoseamine & chondrotin sulphate supplements and acetaminophene as anti-pain drug; Patient tendency and ability to participate in the study. Exclusion criteria: Severe osteoarthritis; Secondary osteoarthritis; Active synovitis; Having a history of knee injection during the past 6 months; Neurological disorder that affects movement, muscle control and balance; Uncontrolled hypertension, diabetes, cardiovascular disorders, chronic kidney disorders and functional liver disorders; Using Furosemide, Probenecid, Anticoagulants, Anticonvulsant, Sulphonamides, Methotrexate, Lithium salts and muscle relaxants; Using antioxidant supplements and w3; Smoking; History of allergy; Pregnancy and or lactation.
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is performed by permuted block randomization (block size: 4) using RAS software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht street- Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
92127
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Bilateral primary osteoarthritis of knee
Primary outcomes
1
Description
pain
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
WOMAC questionnaire
2
Description
joint stiffness
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
WOMAC questionnaire
3
Description
diability
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
Serum inflammatory factors
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
IL-1β and hs-CRP
2
Description
Serum oxidative factors
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Malondialdehide and total antioxidant capacity
3
Description
Serum matrix metalloproteinases
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
matrix metalloproteinase-1 and matrix metalloproteinase-13
4
Description
Nutritional status and dietary intake
Timepoint
Before the intervention and 2 months after the intervention