Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001481782473 Date of Approval: 22/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Quality of life among Children on Dialysis and Omega 3 Fatty Acid Supplementation
Official scientific title Quality of life among Children on Dialysis and effect of Omega 3 Fatty Acid Supplementation
Brief summary describing the background and objectives of the trial End stage renal disease (ESRD) changes the patient’s entire life with the consequent exposure to poor performance at school, peers social struggles, adjustment difficulties experience and psychological stress, besides dietary control and fluid regimes that they should follow and a lifelong dialysis to sustain life. Omega-3 fatty acids (ω-3 FA) are a fatty acids family containing two or more double bonds. Dietary sources are the main sources of ω-3 FA (i.e., they are “essential” fatty acids). Linolenic acid (ALA), the parent ω-3 FA, is derived mostly from vegetable seed oils. Enzymatic conversion of linolenic acid (ALA) to longer chain fatty acids is limited, so individuals are likely to depend on dietary consumption like Coldwater fish to maintain optimal levels of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) levels that are formed in the body from linolenic acid. Generally, ω-3 FA have shown promising results in changing disease processes involving the inflammatory and immune pathways. Although there are diverse clinical applications, ω-3 FA supplementation is neither routinely recommended nor used in the dialysis-dependent population which may be due to a general lack of familiarity with the biochemical and clinical effects of ω-3 FA therapy. But 2005 National Kidney Foundation Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Cardiovascular Disease in Dialysis Patients recommend further investigation in this area. Studies concerning QoL among chronic kidney disease (CKD) children or adolescents are few. The aim of this study was to: -1. Measure the quality of life among children on dialysis and in comparison, to matched controls,2. Study the effect of ω-3 FA administration on quality of life domains among studied patient group, and 3. Study the effect of ω-3 FA administration on renal functions, lipid profile, and inflammatory markers among studied patient group.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/05/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 30/07/2019
Actual Last follow-up date 30/07/2019
Anticipated target sample size (number of participants) 31
Actual target sample size (number of participants) 31
Recruitment status Completed
Publication URL Not yet
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Omega 3 Fatty Acid Supplementation ω-3 FA capsule containing fish Oil 1000 mg 2 ω-3 FA capsules daily for 3 months ω-3 FA capsule containing fish Oil 1000 mg (Eicosapentaenoic acid minimum (EPA) 13% & Docosahexaenoic acid minimum (DHA) 9%), and wheat germ oil (Linoleic Acid 52 – 59 %) (Omega-3 Plus; SEDICO, Giza, Egypt) had been given to every single patient in the study in a dose of 2 ω-3 FA capsules daily for 3 months (with regular follow up and recording of compliance to medications had been taken. 31
Control Group Omega 3 Fatty Acid Dose of 2 ω-3 FA capsules 3 months ω-3 FA capsule containing fish Oil 1000 mg (Eicosapentaenoic acid minimum (EPA) 13% & Docosahexaenoic acid minimum (DHA) 9%), and wheat germ oil (Linoleic Acid 52 – 59 %) (Omega-3 Plus; SEDICO, Giza, Egypt) 31 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with ESRD with - A glomerular filtration rate of less than 10 ml/min/1.73 m2 - Age less than 14 years, and - Regular hemodialysis at least three sessions per week for at least 3 months before the study will be included in the study. Patients with - Pre-dialysis stages of CKD, - On chronic peritoneal dialysis, - Regular hemodialysis < 3 months, - Primary (non-uremic) cardiovascular disease will be excluded from the study. Forty nine patients were enrolled, 31 patients (17 males and 14 females, aged from 8-14 years) fit the inclusion criteria while 18 patients were excluded (due to exclusion criteria, acute infection, hospitalization, febrile illness and non-compliance). Child: 6 Year-12 Year 8 Year(s) 14 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/04/2019 Ethical committee in Menoufia faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Gamal Abdel Nasser st Shibin El kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Study the effect of ω-3 FA administration on quality of life domains among studied patient group 3 months
Secondary Outcome Inflammatory Markers After 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric nephrology unit Gamala abdel nasser st Shebin Elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Samir Gamal Abdel Nasser st Shibin Elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Samir Gamal Abdel Nasser st Shibin Elkom 32511 Egypt Author
COLLABORATORS
Name Street address City Postal code Country
Zeinab Kasemy Gamal Abdel Nasser st Shibin L Kom 32511 Egypt
Hanan Hathout Gamal bdel Nasser st Shibin Elkom 32511 Egypt
Mohamed Samir Gamal Abdel Nasser st Shibin El Kom 32511 Egypt
Zein Omar Gamal Abdel Nasser st Shibin El Kom 32511 Egypt
Wael Bahbah Gamal Abdel Nasser st Shibin El Kom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zeinab Kasemy zeinabkasemy@yahoo.com +201068787807 Gmal Abdel Nasser st
City Postal code Country Position/Affiliation
Shibin El Kom 32511 Egypt Assistant professor at Public Health and Community Medicine Department
Role Name Email Phone Street address
Public Enquiries Zeinab Kasemy zeinbkasemy@yahoo.com +201068787807 Gamal Abdel Nasser
City Postal code Country Position/Affiliation
Shibin El Kom 32511 Egypt Assistant professor at Public health department
Role Name Email Phone Street address
Scientific Enquiries Hanan Hathout han_hathout@yahoo.com +201068787807 Gamal Abdel Nasser
City Postal code Country Position/Affiliation
Shibin El Kom 32511 Egypt Assistant Professor of public health and community medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants’ data that underlie the results reported in the article after deidentification (Protocol, text, tables, figures, and statistical analysis immediately following publication and for a year will be available to anyone who wishes to access the data for any purpose by emailing zeinabkasemy@yahoo.com or https://scholar.google.com/citations?hl=ar&user=52PJoTAAAAAJ Statistical Analysis Plan,Study Protocol One year starting immediately following publication Anyone who wishes to access the data (Protocol, text, tables, figures, and statistical analysis) for any purpose by emailing zeianbkasemy@yahoo.com or sending a request to https://scholar.google.com/citations?hl=ar&user=52PJoTAAAAAJ and the requests will be reviewed by the collaborators
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://scholar.google.com/citations?hl=ar&user=52PJoTAAAAAJ Yes Children with End Stage Renal Disease (ESRD) are liable to have poor quality of life. This work aimed to assess quality of life and study the effect of omega-3 fatty acid (ω-3 FA) supplementation among children on dialysis. A pilot study was conducted on 31 hemodialysis children and an equal number of matched controls. Nonpharmacological treatments include dietary supplementation with ω-3 FA had been given to the patients for 16 weeks. PedsQL Measurement Model to measure quality of life (QOL) and laboratory investigations to assess the condition had been carried out. Patients had poorer QOL in comparison with controls especially regarding health activities (P<0.001). Poor QOL was reported among females and ages <12y (P<0.05). After ω-3 FA supplementation, the scores get improved not to the degree of controls scores but it showed some improvement (P<0.05). Lipid profile, inflammatory markers and efficiency of dialysis showed improvement (P<0.05). QOL among children on dialysis is affected by the disease. Beneficial effects of ω-3 FA were detected in children on dialysis reflected on improved quality of life. Further application on large sample to allow routine use for those patients is needed. 18/01/2020 18/01/2020
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not yet
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