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| [ Print-friendly version ] |
| Omega 3 fatty acid for prevention of sickle cell crisis |
| ISRCTN | ISRCTN80844630 |
| ClinicalTrials.gov identifier | |
| Public title | Omega 3 fatty acid for prevention of sickle cell crisis |
| Scientific title | Omega 3 Fatty Acids for prevention of vaso-occlusive and haemolytic crises in patients with homozygous Sickle Cell Disease (FASCD): a randomised, double-blind, placebo-controlled trial |
| Acronym | FASCD |
| Serial number at source | N/A |
| Study hypothesis |
1. Supplementation with the long-chain polyunsaturated omega-3 fatty acids, docosahexaenoic (DHA) and eicospentaenoic (EPA), will prevent vaso-occlusive and clinical vaso-occluive episodes in patients with homozygous sickle cell disease (HbSS)
2. DHA and EPA supplement will reduce haemolytic crisis, blood transfusion rate and number of school days lost due to illness related to the disease and heamoglobin concentration |
| Lay summary |
Background and study aims
Sickle cell anaemia is an inherited blood disease that affects millions of people worldwide. It is most common in Sub-Sahara Africa and among people whose ancestors come from this region. The disease causes blockage of blood flow and serious damage to the kidneys, lungs, brain and other vital organs of the body. Sickle cell patients at a high risk of organ damage are treated with regular blood transfusions and hydroxyurea. These treatments pose new risks for patients. Moreover, they are not readily available in Sub-Sahara Africa. Hence, there is a need for effective, affordable and safe treatment. The aim of the study is to investigate if omega 3 fatty acids, nutrients obtained from oil fish, prevent blockage of blood flow. Who can participate? 140 male and female patients between 2 and 50 years old with sickle cell anaemia were recruited from the Sickle Cell Referral Clinic, Khartoum Teaching Hospital, Khartoum (Sudan). Patients were not included if: 1. Less than 2 and over 50 years old 2. Receiving or had received blood transfusions in the previous four months 3. On hydroxyurea treatment and 4. Pregnant What does the study involve? The patients were given capsules (pills) with or without omega 3 fatty acids. What are the possible benefits and risks of participating? If omega 3 fatty acids are shown to prevent blockage of blood flow, it will be beneficial to the participants and others who have the disease. Omega 3 fatty acids are nutrients widely present in fish and other marine food and do not present any risk. Where is the study run from? All the patients were recruited from the Sickle Cell Referral Clinic, Ibn-Aoaf Paediatric Hospital (the lead centre) and Khartoum Teaching Hospital, Khartoum, Sudan. When is study starting and how long is it expected to run for? The study started in June 2008 and completed in May 2010. Who is funding the study? 1. Marie Curie Transfer of Knowledge (European Union) 2. University of Khartoum (Sudan) 3. Efamol Limited (UK) 4. The Kitchener School of Medicine Trust Fund (UK) Who is the main contact? Professor Kebreab Ghebremeskel k.ghebremeskel@londonmet.ac.uk |
| Ethics approval |
1. Ethics Committee of the Faculty of Medicine, University of Khartoum, Sudan approved on 19th April 2009
2. Research Ethics Committee of Southampton & South West Hampshire, UK ref: 05/Q1702/48 approved on 18th May 2005 |
| Study design | Randomised double-blind placebo-controlled trial |
| Countries of recruitment | Sudan |
| Disease/condition/study domain | Sickle cell anaemia (HbSS) |
| Participants - inclusion criteria |
1. HbSS phenotype
2. Male and female participants 3. Steady state 4. Aged 2 to 50 years old |
| Participants - exclusion criteria |
1. Other phenotypes
2. Patients in crisis 3. Patients on hydroxyurea treatment 4. Presence of other chronic diseases 5. Blood transfusion in the previous four months 6. Pregnancy 7. Previous history of overt stroke |
| Anticipated start date | 12/06/2008 |
| Anticipated end date | 30/05/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 140 |
| Interventions |
The subjects, after stratification by age and gender, will be randomly assigned to receive coded and indistinguishable omega 3 (n=70) or placebo (n=70) capsules.
Subsequent to randomisation, the patients will be given, daily for one year, one (2-4 year old), two (5-10), three (11-16) or four (≥ 17) omega 3 containing 277.8 mg DHA and 39.0 mg EPA or high oleic acid (41%) oil blend placebo capsules. The antioxidant vitamin E, 1.5mg/capsule, was added to the omega 3 and placebo to prevent peroxidation. Enrolment identification number, gender, residence, ethnicity, weight, height, history of blood transfusion and stroke, number of sickle cell-related hospital admission during the previous years and sickle cell complication data will be collected using a validated structured questionnaire at baseline. Monthly self-assessment health diary will be given to each patient to daily record, pain frequency and intensity, pain medication taken and hospitalisation. Name and telephone number of the medical doctor in charge will be given to the patients and their guardians in case they require advice or care outside normal working hours. During each monthly follow-up, the self-recorded health diaries will be reviewed, patients examined thoroughly and the data obtained entered into the database by the same physician. Whole blood, about 10 ml, will be obtained from the patients at recruitment and after one year of intervention for haematological and biochemical analyses. |
| Primary outcome measure(s) |
1. Annualised rates of clinical vaso-occlusive crisis is defined as painful events that lead to hospitalisation.
1.1. Vaso-occlusive crisis is defined as a painful event characterised by musculoskeletal and/or visceral pain which is usually associated with mild pyrexia and the passage of dark or red urine. |
| Secondary outcome measure(s) |
1. Haemolytic crisis
2. Rate of blood transfusion 3. School attendance 4. Hb level and mean cell volume (MCV) |
| Sources of funding |
1. Marie Curie Transfer of Knowledge (EU) (ref: MTKD-CT-2005-029914)
2. University of Khartoum (Sudan) 3. Efamol Limited (UK) 4. The Kitchener School of Medicine Trust Fund (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Kebreab Ghebremeskel |
| Address |
Faculty of Life Sciences
London Metropolitan University 166 - 220 Holloway Road |
| City/town | London |
| Zip/Postcode | N7 8DB |
| Country | United Kingdom |
| k.ghebremeskel@londonmet.ac.uk | |
| Sponsor | Mother and Child Foundation (UK) |
| Address | 36 Regents Park Road |
| City/town | London |
| Zip/Postcode | NW1 7SX |
| Country | United Kingdom |
| Sponsor website: | http://www.mother-and-child.org/ |
| Date applied | 15/12/2011 |
| Last edited | 24/01/2012 |
| Date ISRCTN assigned | 23/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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