Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of omega-3 fatty acid supplementation on inflammatory markers and advanced glycation end products in diabetic nephropathy patients.
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Design
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Randomized, double-blind, placebo-controlled clinical trial, phase 3, 60 patients
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Settings and conduct
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60 patients with diabetic nephropathy of eligible and referred to Akhavan Clinic, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients with diabetic nephropathy with FPG ≥ 126 mg/dl less than 15 years of their disease aged 45 to 85 years.
Exclusion Criteria: The intake of omega-3 fatty acid supplements within the past 3 months, uncontrolled diabetes mellitus, current use of warfarin, malignancy, liver cirrhosis, smoking.
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Intervention groups
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Intervention group: Omega-3 fatty acid pearl, 1000 mg, daily, for 12 weeks orally.
Control group: Placebo pearl, daily, for 12 weeks orally.
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Main outcome variables
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Outcomes: Inflammatory markers (primary outcomes) and advanced glycation end products (secondary outcomes) will be measured at baseline and End-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201504095623N41
Registration date:
2015-04-10, 1394/01/21
Registration timing:
prospective
Last update:
2019-09-28, 1398/07/06
Update count:
1
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Registration date
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2015-04-10, 1394/01/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2015-04-16, 1394/01/27
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Expected recruitment end date
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2015-04-22, 1394/02/02
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of omega-3 fatty acid supplementation on inflammatory markers and advanced glycation end products in diabetic nephropaty patients
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Public title
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Effects omega-3 fatty acid supplementation in the treatment of diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion Criteria: Patients with diabetic nephropathy with FPG ≥ 126 mg/dl less than 15 years of their disease aged 45 to 85 years.
Exclusion criteria:
The intake of omega-3 fatty acid supplements within the past 3 months
Uncontrolled diabetes mellitus
Current use of warfarin
Malignancy
Liver cirrhosis
Smoking
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Age
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From 45 years old to 85 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, after balanced blocked randomisation, all participants will have allocated into two treatment groups to take either supplement or placebo. Randomization will be done by the use of Stat Trek software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-04-07, 1394/01/18
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Ethics committee reference number
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5979
Health conditions studied
1
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Description of health condition studied
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Diabetic Nephropathy
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ICD-10 code
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N08.3
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ICD-10 code description
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Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+)
Primary outcomes
1
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Description
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Tumor Necrosis Factor alpha (TNFα)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa
2
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Description
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Receptor of Tumor Necrosis Factor alpha (TNFα)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa
Secondary outcomes
1
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Description
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Receptor of Advanced Glycation End Products
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa
2
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Description
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Advanced Glycation End Products
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Fluorometeric method
Intervention groups
1
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Description
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Intervention group: Omega-3 fatty acid pearl, 1000 mg, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo pearl, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available