Effect of omega-3 supplementation on myelination, inflammation, and chronic fatigue in patients with multiple sclerosis

Evaluation of the effect of omega-3 supplementation on serum levels of brain-derived neurotrophic factor, high-sensitivity C-reactive protein, and chronic fatigue in patients with multiple sclerosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240604062003N1

Enrollment

Registered

2024-07-28

Start date

2024-05-30

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis. Multiple sclerosis (of):NOS brain stem cord disseminated generalized

Interventions

Intervention 1: Intervention group: recipients of omega-3 fatty acid soft capsules with a dose of 1000 mg/d (Zahravai, Tabriz, Iran) twice a day for 12 weeks. Intervention 2: Control group: recipients

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Age 18-85 years MS diagnosis by a neurologist based on McDonald's criteria (98) Under treatment with MS-modifying drugs with a fixed dose from 6 months before enrolling in the study

Exclusion criteria

Exclusion criteria: Participants in other trials except for the current clinical trial Recurrence or treatment with corticosteroids in the last month- Simultaneous treatment with antibiotics and antihypertensive drugs Other acute or severe diseases except for MS Pregnancy Current or past history of ventricular arrhythmia General health condition that interferes with participation in the study.

Design outcomes

Primary

Measure	Time frame
Mean of high sensitive C-reactive protein serum levels. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Measurement of hs-CRP: The obtained blood samples will be used to measure the serum inflammatory factor hs-CRP by the Turbidimetric immunoassay (immunoturbidimetry) method.;Mean of Brain-derived neurotrophic factors serum levels. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Measurement of BDNF by ELISA: Blood samples will be collected at the beginning and end of the study from all participants between 9:00 and 12:30 to measure total BDNF levels in the serum and clotted for 1 hour at room temperature and then 1 hour at room temperature. It is placed at 4 degrees Celsius. Then, the serum was separated using a centrifuge at 2000 rpm for 10 minutes at 4°C, aliquoted, and stored at -80°C until use in 0.2 ml tube strips (Sarstedt, Multiply® µStripPro). To measure total BDNF serum level, the ELISA kit manufactured by Zelbio, Germany will be used (99).	—

Measure

Time frame

Mean of high sensitive C-reactive protein serum levels. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Measurement of hs-CRP: The obtained blood samples will be used to measure the serum inflammatory factor hs-CRP by the Turbidimetric immunoassay (immunoturbidimetry) method.;Mean of Brain-derived neurotrophic factors serum levels. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Measurement of BDNF by ELISA: Blood samples will be collected at the beginning and end of the study from all participants between 9:00 and 12:30 to measure total BDNF levels in the serum and clotted for 1 hour at room temperature and then 1 hour at room temperature. It is placed at 4 degrees Celsius. Then, the serum was separated using a centrifuge at 2000 rpm for 10 minutes at 4°C, aliquoted, and stored at -80°C until use in 0.2 ml tube strips (Sarstedt, Multiply® µStripPro). To measure total BDNF serum level, the ELISA kit manufactured by Zelbio, Germany will be used (99).

—

Secondary

Measure	Time frame
Mean of chronic fatigue scale score. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Assessment of chronic fatigue scale score: A questionnaire consisting of 10 "physical" items, 10 "cognitive" items, and 20 "social" items is used to measure the extent of chronic fatigue of patients in the last 4 weeks.;Measure of physical activity. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: To evaluate physical activity, the International Physical Activity Questionnaire (IPAQ) is used.	—

Measure

Time frame

Mean of chronic fatigue scale score. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Assessment of chronic fatigue scale score: A questionnaire consisting of 10 "physical" items, 10 "cognitive" items, and 20 "social" items is used to measure the extent of chronic fatigue of patients in the last 4 weeks.;Measure of physical activity. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: To evaluate physical activity, the International Physical Activity Questionnaire (IPAQ) is used.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahshid Naghashpour

Abadan University of Medical Sciences

mnaghashpour@gmail.com+98 916 615 7338

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026