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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03260231 |
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Date of registration:
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11/08/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
Lymphoseed |
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Scientific title:
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Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma |
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Date of first enrolment:
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May 12, 2017 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03260231 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Zorica Cvetkovic, MD PhD |
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Address:
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Telephone:
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+381641302624 |
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Email:
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zokabora@yahoo.com |
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Affiliation:
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Name:
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Vesna Vucic, PhD |
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Address:
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Telephone:
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+381113031997 |
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Email:
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vesna.vucic.imr@gmail.com |
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Affiliation:
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Name:
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Vesna Vucic, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute for medical research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed Non-Hodgkin lymphoma
- Patients able to understand requirements of the study and provide written informed
consent
Exclusion Criteria:
- Previous radio- or chemotherapy
- Other serious chronic diseases
- Statin therapy
- Presence of allergy on any seeds
- Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3
months prior to study
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-hodgkin Lymphoma
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Intervention(s)
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Dietary Supplement: Milled seed mix
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Primary Outcome(s)
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Change in disease status
[Time Frame: Baseline, 5 months, 1 year]
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Change in quality of life questionnaire scores
[Time Frame: Baseline, 5 months, 1 year]
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Secondary Outcome(s)
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Changes in lipid profiles
[Time Frame: Baseline, 5 months, 1 year]
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Changes in parameters of oxidative stress
[Time Frame: Baseline, 5 months]
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Changes in body weight
[Time Frame: Baseline, 5 months, 1 year]
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Changes in CRP
[Time Frame: Baseline, 5 months, 1 year]
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Changes in leukocyte count
[Time Frame: Baseline, 5 months, 1 year]
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Changes in interleukin (IL)-6
[Time Frame: Baseline, 5 months, 1 year]
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Changes in plasma fatty acids
[Time Frame: Baseline, 5 months, 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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