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IRCT20090901002394N42 IRCT 2019-03-15 Iran University of Medical Sciences Effect of collagen and fish oil in burn - Effect of hydrolyzed collagen alone, or in combination with fish oil on wound healing, metabolic disorders and adipose derived peptides in patients with burn 2019-04-04 anticipated 66 Complete https://irct.ir/trial/37517 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: For random allocation of individuals to the three groups, the permuted block randomization method will be applied, using a computer program, and the length of blocks will be considered randomly as 3, 6 or 9, Blinding description: The participants in this study and the main investigator who will be involved in the conduction of the project will be blind to the content of supplement and placebo. The allocation of individuals and the provision of supplement and placebo will be carried out by a person independent of the research group. N/A Condition 1: Burns. Condition 2: Burns. Condition 3: Burns. Intervention 1: Intervention group 1: Daily intake of 40 gr hydrolyzed collagen for 4 weeks. Intervention 2: Intervention group 2: Daily intake of 40 gr hydrolyzed collagen plus 10 ml fish oil for 4 weeks. Intervention 3: Control group: Placebo with same characteristics for 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Shima Jazayeri
Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 sjazayeri@razi.tums.ac.ir Iran University of Medical Sciences scientific Shima Jazayeri
Iran University of Medical Sciences, Hemmat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 sjazayeri@razi.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with 20-45% total body surface area burn Patients with burn degree of 2 (deep) or 3 Age 18-60 years The ability of oral intake of foods 18 years 60 years Both History of any metabolic or chronic diseases such as diabetes, cardiovascular diseases, organ failures, and etc. Body mass index < 18.5 kg/m2 History of allergy or intolerance to protein products Pregnant women Drug and alcohol addicts T21 T22 T24 Burn and corrosion of trunk Burn and corrosion of shoulder and upper limb, except wrist and hand Burn and corrosion of lower limb, except ankle and foot Treatment - Other Treatment - Other Placebo Intervention group 1: Daily intake of 40 gr hydrolyzed collagen for 4 weeks Intervention group 2: Daily intake of 40 gr hydrolyzed collagen plus 10 ml fish oil for 4 weeks Control group: Placebo with same characteristics for 4 weeks Pre-albumin serum concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: Biochemical assay. Body weight. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: Body scale. Body mass index. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: Calculation based on the relevant formula. Duration of hospital stay. Timepoint: Time of discharge. Method of measurement: Patient's records. Wound healing. Timepoint: End of weeks 2 and 4. Method of measurement: Observation. High-sensitivity C-reactive Protein serum concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: ELISA. Transforming growth factor beta serum concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: ELISA. Adiponectin serum concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: ELISA. Fasting blood glucose concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: Biochemical assay. Fasting insulin serum concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: ELISA. Homeostasis model assessment of insulin resistance. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: Calculation based on the relevant formula. Daily energy intake. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: 24-h dietary recall. Daily protein intake. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: 24-h dietary recall. Fibroblast growth factor 21 serum concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: ELISA. Neuregulin 4 serum concentration. Timepoint: Baseline, end of weeks 2 and 3. Method of measurement: ELISA. Vancouver Scar Scale. Timepoint: End of week 4. Method of measurement: Scoring based on a questionnaire. Tehran University of Medical Sciences Iran University of Medical Sciences Tehran University of Medical Sciences Approved 2018-10-28 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)