MigrainePhase 4NCT02532023
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
A Phase 4 study testing omega 3 fatty acid and curcumin in people with Migraine, run by Tehran University of Medical Sciences.
Trial summary
The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Migraine
- What is being tested?
- omega 3 fatty acid and curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- migraine patients 20- 50 years old
- body mass index more than 18.5
- avoidance of dietary supplements, vitamins and herbal products at least 4-6 weeks before and throughout the intervention
- willingness to participation
Who cannot join
- sensitivity to omega 3 fatty acid and curcumin
- pregnancy and lactation
- sever change in regular diet and life style
- change in type and dosage of regular medication (s)
- inflammatory disease which need take anti inflammatory drugs over than 2 weeks
About this study
Official title: The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Gene Expression and Serum Levels of Some Inflammatory and Endothelial Factors in Migraine Patients
The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.
Read the detailed description
The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), Tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1) in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and high-sensitivity C-reactive protein (hsCRP) of migraine patients.
In this randomized, double-blind clinical trial, placebo-controlled study, 80 women and men with migraine are enrolled from the Iranian Center of Neurological Research. At the start of study, all participants will sign informed consent and complete a general information form. 24-hour food recall for 3 days will be taken from the patients at the beginning and the end of the study. Selected samples by using stratified randomization method based on sex, gender and body mass index (BMI) are classified into 4 groups: 1) receiving omega 3 fatty acid supplement and curcumin supplement 2) receiving omega 3 fatty acid supplement and curcumin placebo 3) receiving curcumin supplement and omega 3 fatty acid placebo 4) receiving omega 3 fatty acid placebo and curcumin placebo.
The omega 3 fatty acid supplement group will receive 1200 mg Eicosapentaenoic acid (EPA) and 600 mg Docosahexaenoic acid (DHA) totally 1800 mg daily for 2 months. The curcumin supplement group will receive 1000 mg curcumin daily for 2 months. The omega 3 fatty acid placebo group will also receive placebo containing 1800 mg edible paraffin oil and curcumin placebo group will receive 1000 mg starch powder both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.
- Conditions
- Migraine
- Being tested
- omega 3 fatty acid, curcumin, omega 3 fatty acid placebo, curcumin placebo
- Keywords
- omega 3 fatty acid, curcumin, COX-2, iNOs, VCAM-1, ICAM-1, IL-1β, IL-6, TNF-α, hsCRP, migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3 fatty acidDietary supplement
Also called n-3 PUFA, n-3 Fatty Acid
omega 3 fatty acid supplement, 2× 1000 mg softgel daily (1800 mg EPA+DHA per day), 2 times a day, for 2 months
curcuminDietary supplement
curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months
omega 3 fatty acid placeboDietary supplement
omega 3 fatty acid placebo softgel (Containing 2 g edible paraffin oil), 2× 1000 mg softgel daily (2 g per day), 2 times a day, for 2 months
curcumin placeboDietary supplement
curcumin placebo softgel (Containing 1 g starch powder), 2× 500 mg softgel daily (1 g per day), 2 times a day, for 2 months
| Study group | Role | What they receive |
|---|---|---|
| omega 3 fatty acid supplementation | Active comparator | patients with migraine receive 2 capsules 1000 mg omega3, 2 times a day, for 2 months. Receives: Dietary Supplement: omega 3 fatty acid |
| curcumin supplementation | Active comparator | patients with migraine receive 2 capsules 1000 mg curcumin, 2 times a day, for 2 months. Receives: Dietary Supplement: curcumin |
| omega 3 fatty acid Placebo | Placebo comparator | patients with migraine receive 2 capsules of omega 3 fatty acid placebo for 2 months. Receives: Dietary Supplement: omega 3 fatty acid placebo |
| curcumin placebo | Placebo comparator | patients with migraine receive 2 capsules of curcumin placebo for 2 months. Receives: Dietary Supplement: curcumin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
headache attack
Measured: Change frome baseline at 2 months
Secondary outcomes (17)
serum COX-2
Measured: Change frome baseline at 2 months
serum iNOs
Measured: Change frome baseline at 2 months
serum VCAM-1
Measured: Change frome baseline at 2 months
serum ICAM-1
Measured: Change frome baseline at 2 months
serum TNF-α
Measured: Change frome baseline at 2 months
serum IL-1β
Measured: Change frome baseline at 2 months
serum IL-6
Measured: Change frome baseline at 2 months
serum hsCRP
Measured: Change frome baseline at 2 months
headache duration
Measured: Change frome baseline at 2 months
headache severity
Measured: Change frome baseline at 2 months
COX-2 gene expression
Measured: Change frome baseline at 2 months
iNOs gene expression
Measured: Change frome baseline at 2 months
VCAM-1 gene expression
Measured: Change frome baseline at 2 months
ICAM-1 gene expression
Measured: Change frome baseline at 2 months
TNF-α gene expression
Measured: Change frome baseline at 2 months
IL-1β gene expression
Measured: Change frome baseline at 2 months
IL-6 gene expression
Measured: Change frome baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532023
- Sponsor's protocol ID
- 28825
- Status last verified
- Aug 2015
- First submitted
- 21 Aug 2015
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Djalali M, Talebi S, Djalali E, Abdolahi M, Travica N, Djalali M. The effect of omega-3 fatty acids supplementation on inflammatory biomarkers in subjects with migraine: a randomized, double-blind, placebo-controlled trial. Immunopharmacol Immunotoxicol. 2023 Oct;45(5):565-570. doi: 10.1080/08923973.2023.2196600. Epub 2023 Apr 26.
PubMed 37126739Abdolahi M, Karimi E, Sarraf P, Tafakhori A, Siri G, Salehinia F, Sedighiyan M, Asanjarani B, Badeli M, Abdollahi H, Yoosefi N, Yousefi A, Rad AS, Djalali M. The omega-3 and Nano-curcumin effects on vascular cell adhesion molecule (VCAM) in episodic migraine patients: a randomized clinical trial. BMC Res Notes. 2021 Jul 23;14(1):283. doi: 10.1186/s13104-021-05700-x.
PubMed 34301320Abdolahi M, Sarraf P, Javanbakht MH, Honarvar NM, Hatami M, Soveyd N, Tafakhori A, Sedighiyan M, Djalali M, Jafarieh A, Masoudian Y, Djalali M. A Novel Combination of omega-3 Fatty Acids and Nano-Curcumin Modulates Interleukin-6 Gene Expression and High Sensitivity C-reactive Protein Serum Levels in Patients with Migraine: A Randomized Clinical Trial Study. CNS Neurol Disord Drug Targets. 2018;17(6):430-438. doi: 10.2174/1871527317666180625101643.
PubMed 29938621
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Gene Expression and Serum Levels of Some Inflammatory and Endothelial Factors in Migraine Patients
- ClinicalTrials.gov ID
- NCT02532023
- Acronym / sponsor ID
- 28825
- Conditions
- Migraine
- Keywords
- omega 3 fatty acid, curcumin, COX-2, iNOs, VCAM-1, ICAM-1, IL-1β, IL-6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.
Detailed description
The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), Tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1) in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and high-sensitivity C-reactive protein (hsCRP) of migraine patients.
In this randomized, double-blind clinical trial, placebo-controlled study, 80 women and men with migraine are enrolled from the Iranian Center of Neurological Research. At the start of study, all participants will sign informed consent and complete a general information form. 24-hour food recall for 3 days will be taken from the patients at the beginning and the end of the study. Selected samples by using stratified randomization method based on sex, gender and body mass index (BMI) are classified into 4 groups: 1) receiving omega 3 fatty acid supplement and curcumin supplement 2) receiving omega 3 fatty acid supplement and curcumin placebo 3) receiving curcumin supplement and omega 3 fatty acid placebo 4) receiving omega 3 fatty acid placebo and curcumin placebo.
The omega 3 fatty acid supplement group will receive 1200 mg Eicosapentaenoic acid (EPA) and 600 mg Docosahexaenoic acid (DHA) totally 1800 mg daily for 2 months. The curcumin supplement group will receive 1000 mg curcumin daily for 2 months. The omega 3 fatty acid placebo group will also receive placebo containing 1800 mg edible paraffin oil and curcumin placebo group will receive 1000 mg starch powder both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| omega 3 fatty acid supplementation | Active comparator | Dietary Supplement: omega 3 fatty acidpatients with migraine receive 2 capsules 1000 mg omega3, 2 times a day, for 2 months. |
| curcumin supplementation | Active comparator | Dietary Supplement: curcuminpatients with migraine receive 2 capsules 1000 mg curcumin, 2 times a day, for 2 months. |
| omega 3 fatty acid Placebo | Placebo comparator | Dietary Supplement: omega 3 fatty acid placebopatients with migraine receive 2 capsules of omega 3 fatty acid placebo for 2 months. |
| curcumin placebo | Placebo comparator | Dietary Supplement: curcumin placebopatients with migraine receive 2 capsules of curcumin placebo for 2 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- migraine patients 20- 50 years old
- body mass index more than 18.5
- avoidance of dietary supplements, vitamins and herbal products at least 4-6 weeks before and throughout the intervention
- willingness to participation
Key exclusion criteria (5 listed)
- sensitivity to omega 3 fatty acid and curcumin
- pregnancy and lactation
- sever change in regular diet and life style
- change in type and dosage of regular medication (s)
- inflammatory disease which need take anti inflammatory drugs over than 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega 3 fatty acidAlso: n-3 PUFA, n-3 Fatty Acidomega 3 fatty acid supplement, 2× 1000 mg softgel daily (1800 mg EPA+DHA per day), 2 times a day, for 2 months | Dietary supplement | omega 3 fatty acid supplementation |
| curcumincurcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months | Dietary supplement | curcumin supplementation |
| omega 3 fatty acid placeboomega 3 fatty acid placebo softgel (Containing 2 g edible paraffin oil), 2× 1000 mg softgel daily (2 g per day), 2 times a day, for 2 months | Dietary supplement | omega 3 fatty acid Placebo |
| curcumin placebocurcumin placebo softgel (Containing 1 g starch powder), 2× 500 mg softgel daily (1 g per day), 2 times a day, for 2 months | Dietary supplement | curcumin placebo |
Primary outcome
headache attack
Time frame: Change frome baseline at 2 months
17 secondary outcomes
serum COX-2
Time frame: Change frome baseline at 2 months
serum iNOs
Time frame: Change frome baseline at 2 months
serum VCAM-1
Time frame: Change frome baseline at 2 months
serum ICAM-1
Time frame: Change frome baseline at 2 months
serum TNF-α
Time frame: Change frome baseline at 2 months
serum IL-1β
Time frame: Change frome baseline at 2 months
serum IL-6
Time frame: Change frome baseline at 2 months
serum hsCRP
Time frame: Change frome baseline at 2 months
headache duration
Time frame: Change frome baseline at 2 months
headache severity
Time frame: Change frome baseline at 2 months
COX-2 gene expression
Time frame: Change frome baseline at 2 months
iNOs gene expression
Time frame: Change frome baseline at 2 months
VCAM-1 gene expression
Time frame: Change frome baseline at 2 months
ICAM-1 gene expression
Time frame: Change frome baseline at 2 months
TNF-α gene expression
Time frame: Change frome baseline at 2 months
IL-1β gene expression
Time frame: Change frome baseline at 2 months
IL-6 gene expression
Time frame: Change frome baseline at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Derived from this study: PubMed 37126739Djalali M, Talebi S, Djalali E, Abdolahi M, Travica N, Djalali M. The effect of omega-3 fatty acids supplementation on inflammatory biomarkers in subjects with migraine: a randomized, double-blind, placebo-controlled trial. Immunopharmacol Immunotoxicol. 2023 Oct;45(5):565-570. doi: 10.1080/08923973.2023.2196600. Epub 2023 Apr 26.
- Derived from this study: PubMed 34301320Abdolahi M, Karimi E, Sarraf P, Tafakhori A, Siri G, Salehinia F, Sedighiyan M, Asanjarani B, Badeli M, Abdollahi H, Yoosefi N, Yousefi A, Rad AS, Djalali M. The omega-3 and Nano-curcumin effects on vascular cell adhesion molecule (VCAM) in episodic migraine patients: a randomized clinical trial. BMC Res Notes. 2021 Jul 23;14(1):283. doi: 10.1186/s13104-021-05700-x.
- Derived from this study: PubMed 29938621Abdolahi M, Sarraf P, Javanbakht MH, Honarvar NM, Hatami M, Soveyd N, Tafakhori A, Sedighiyan M, Djalali M, Jafarieh A, Masoudian Y, Djalali M. A Novel Combination of omega-3 Fatty Acids and Nano-Curcumin Modulates Interleukin-6 Gene Expression and High Sensitivity C-reactive Protein Serum Levels in Patients with Migraine: A Randomized Clinical Trial Study. CNS Neurol Disord Drug Targets. 2018;17(6):430-438. doi: 10.2174/1871527317666180625101643.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omega 3 fatty acid and curcumin in people with Migraine, run by Tehran University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
headache attack (time frame: Change frome baseline at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532023, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.