Condition category
Haematological Disorders
Date applied
15/12/2011
Date assigned
23/01/2012
Last edited
10/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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).

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

Trial website

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/

Contact information

Type

Scientific

Primary contact

Prof Kebreab Ghebremeskel

ORCID ID

Contact details

Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing
London Metropolitan University
166 - 220 Holloway Road
London
N7 8DB
United Kingdom
-
k.ghebremeskel@londonmet.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

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

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

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 measures

1. Haemolytic crisis
2. Rate of blood transfusion
3. School attendance
4. Hb level and mean cell volume (MCV)

Overall trial start date

12/06/2008

Overall trial end date

30/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. HbSS phenotype
2. Male and female participants
3. Steady state
4. Aged 2 to 50 years old

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

140

Participant 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

Recruitment start date

12/06/2008

Recruitment end date

30/05/2010

Locations

Countries of recruitment

Sudan

Trial participating centre

Lipidomics and Nutrition Research Centre,
Faculty of Life Sciences and Computing, London Metropolitan University
London
N7 8DB
United Kingdom

Trial participating centre

Faculty of Medicine,
University of Khartum,
Khartum
Sudan

Trial participating centre

Sickle Cell Disease Clinic Abnaof Paediatric Hospital,
Khartum
Sudan

Sponsor information

Organisation

Mother and Child Foundation (UK)

Sponsor details

36 Regents Park Road
London
NW1 7SX
United Kingdom

Sponsor type

Charity

Website

http://www.mother-and-child.org/

Funders

Funder type

Research organisation

Funder name

Marie Curie Transfer of Knowledge (EU) (ref: MTKD-CT-2005-029914)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Khartoum (Sudan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Efamol Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Kitchener School of Medicine Trust Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23193009
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24095588
2013 results in: http://onlinelibrary.wiley.com/doi/10.1002/lite.201300308/abstract
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25976467

Publication citations

  1. Results

    Daak AA, Ghebremeskel K, Hassan Z, Attallah B, Azan HH, Elbashir MI, Crawford M, Effect of omega-3 (n-3) fatty acid supplementation in patients with sickle cell anemia: randomized, double-blind, placebo-controlled trial., Am. J. Clin. Nutr., 2013, 97, 1, 37-44, doi: 10.3945/ajcn.112.036319.

  2. Results

    Daak AA, Ghebremeskel K, Mariniello K, Attallah B, Clough P, Elbashir MI, Docosahexaenoic and eicosapentaenoic acid supplementation does not exacerbate oxidative stress or intravascular haemolysis in homozygous sickle cell patients., Prostaglandins Leukot Essent Fatty Acids, 2013, 89, 5, 305-311, doi: 10.1016/j.plefa.2013.09.006.

  3. Results

    Daak AA, Ghebremeskel K, Omega-3 fatty acids and sickle cell disease: Intriguing association and promising therapeutic effect, Lipid Technology, 2013, 25, 12, 275-277, doi: 10.1002/lite.201300308.

  4. Results

    Daak AA, Elderdery AY, Elbashir LM, Mariniello K, Mills J, Scarlett G, Elbashir MI, Ghebremeskel K, Omega 3 (n-3) fatty acids down-regulate nuclear factor-kappa B (NF-κB) gene and blood cell adhesion molecule expression in patients with homozygous sickle cell disease., Blood Cells Mol Dis, 2015, 55, 1, 48-55, doi: 10.1016/j.bcmd.2015.03.014.

Additional files

Editorial Notes