Omega 3 fatty acid for prevention of sickle cell crisis

ISRCTN	ISRCTN80844630
DOI	https://doi.org/10.1186/ISRCTN80844630
Protocol serial number	N/A
Sponsor	Mother and Child Foundation (UK)
Funders	Marie Curie Transfer of Knowledge (EU) (ref: MTKD-CT-2005-029914), University of Khartoum (Sudan), Efamol Limited (UK), The Kitchener School of Medicine Trust Fund (UK)

Submission date: 15/12/2011
Registration date: 23/01/2012
Last edited: 16/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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).

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 the 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

Contact information

Prof Kebreab Ghebremeskel
Scientific

Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing
London Metropolitan University
166 - 220 Holloway Road
London
N7 8DB
United Kingdom

Email	k.ghebremeskel@londonmet.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	FASCD
Study objectives	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 Protocol can be found at: http://www.londonmet.ac.uk/faculties/faculty-of-life-sciences-and-computing/research/lipidomics-and-nutrition-research-centre/research-projects/current/sickle-cell-disease---alternative-dietary-lipid-therapy/
Ethics approval(s)	1. Ethics Committee of the Faculty of Medicine, University of Khartoum, Sudan, 19/04/2009 2. Research Ethics Committee of Southampton & South West Hampshire, UK, 18/05/2005, ref: 05/Q1702/48
Health condition(s) or problem(s) studied	Sickle cell anaemia (HbSS)
Intervention	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.
Intervention type	Supplement
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.
Key secondary outcome measure(s)	1. Haemolytic crisis 2. Rate of blood transfusion 3. School attendance 4. Hb level and mean cell volume (MCV)
Completion date	30/05/2010

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	All
Target sample size at registration	140
Key inclusion criteria	1. HbSS phenotype 2. Male and female participants 3. Steady state 4. Aged 2 to 50 years old
Key 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
Date of first enrolment	12/06/2008
Date of final enrolment	30/05/2010

Locations

Countries of recruitment

United Kingdom
England
Sudan

Study participating centres

Lipidomics and Nutrition Research Centre,

Faculty of Life Sciences and Computing
London Metropolitan University
London
N7 8DB
United Kingdom

Faculty of Medicine,

University of Khartum
Khartum
-
Sudan

Sickle Cell Disease Clinic Abnaof Paediatric Hospital,

Khartum
-
Sudan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2013		Yes	No
Results article	results	01/10/2013		Yes	No
Results article	results	01/12/2013		Yes	No
Results article	results	01/06/2015		Yes	No
Results article	results	01/10/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/04/2019: Publication reference added.