A CLINICAL TRIAL TO DETERMINE THE EFFECT A FOOD (MAYONNAISE), ENRICHED WITH DOCOSAHEXAENOIC ACID (DHA)IN SICKLE CELL PATIENTS
- Conditions
- Health Condition 1: D571- Sickle-cell disease without crisis
- Registration Number
- CTRI/2022/06/042963
- Lead Sponsor
- RAJALAKSHMI HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Male and non-pregnant female patients 6 ââ?¬â?? 40 years of age
ïâ??· Confirmed diagnosis of sickle cell disease. All sickle cell disease genotypes are eligible
ïâ??· Experienced at least 1 VOC within the preceding 12 months prior to Screening, as
determined by medical history
ïâ??· If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the
drug for at least 6 months prior to Screening
ïâ??· Hemoglobin ââ?°Â¥4.0 g/dL. Absolute neutrophil count ââ?°Â¥1.0 x 109/L and platelet count ââ?°Â¥75 x
109/L
ïâ??· Adequate renal and hepatic function as defined:
ïâ??§ GFR ââ?°Â¥45 mL/min/1.73 m2 calculated by CKD-EPI
ALT �3 x ULN
ïâ??§ Direct (conjugated) bilirubin ââ?°Â¤2 x ULN
ïâ??§ ECOG performance status ââ?°Â¤2
ïâ??· Willing to comply with all requirements of this study protocol as well as instructions by
the study personnel.
ïâ??· No other clinically significant abnormal finding onMedical history, physical
examination (including but may not be limited to an evaluation of the cardiovascular,
gastrointestinal, respiratory, musculoskeletal and central nervous systems).
History of stem cell transplant
ïâ??· Acute VOC ending 7 days prior to first dosing
ïâ??· Ongoing hospitalization prior to Screening
ïâ??· Received blood products within 30 days to first dosing
ïâ??· Participating in a chronic transfusion program (pre-planned series of transfusions for
prophylactic purposes)
ïâ??· If the patient has undergone any experimental oral intervention within the last 24 hours.
ïâ??· History of alcohol addiction or abuse.
ïâ??· Patient who had participated in any other study within the 90 days of study
ïâ??· Females likely to become pregnant during conducting of the study
ïâ??· Pregnant and Lactating females.
Consumption of tobacco containing products Tobacco and tobacco products (like
Khutkha, Pan/ Pan Masala, Beedi, Cigarettes) for at least 24.00 hours prior to screening
and throughout the entire study
ïâ??· Consumption of vaping products
ïâ??· Any other major illness in the last 03 months or any other significant ongoing chronic
medical illness.
ïâ??· Evidence of allergy or known hypersensitivity to Omega 3 fatty acid (DHATG) in
Mayonnaiseand its components.
ïâ??· Any allergy to mayonnaise and its components
ïâ??· History of dehydration from diarrhea, vomiting or any other reason within a period of
48.00 hours prior to study check-in of each visit.
ïâ??· Patients with any condition which in the opinion of the investigator makes the patient
unsuitable for inclusion
ïâ??· Patients with Malignancy or a history of malignancy
ïâ??· Patients with Positive results for HIV or Hepatitis B or C
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the percentage change in the total blood cell <br/ ><br>membrane DHA and EPA concentration from baseline and after 30 days of treatment <br/ ><br>To monitor the safety and tolerability of DHA enriched food <br/ ><br>in patients with sickle cell disease for 30 days post treatmentTimepoint: Visit 01 Screening and enrollment (Day 1) <br/ ><br>Visit 02 Primary end point & end of study visit (Day 28)
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of DHA enriched food <br/ ><br>in patients with sickle cell disease for 30 days post treatment.Timepoint: Visit 01:Screening and enrollment (Day -1) <br/ ><br>Visit 02: Primary end point & end of study visit (Day 28)