Health Condition 1: D571- Sickle-cell disease without crisis
Conditions
Interventions
Intervention1: Omega 3 fatty acid: A single packet of the Omega 3 enriched mayonnaise will be administered once a day for 28 days at ambient temperature.
Frequency - Once a day for 28 days
Total Durat
Sponsors
RAJALAKSHMI HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: 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 ââ?°Â¤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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the percentage change in the total blood cell membrane DHA and EPA concentration from baseline and after 30 days of treatment To monitor the safety and tolerability of DHA enriched food in patients with sickle cell disease for 30 days post treatmentTimepoint: Visit 01 Screening and enrollment (Day 1) Visit 02 Primary end point & end of study visit (Day 28) | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of DHA enriched food in patients with sickle cell disease for 30 days post treatment.Timepoint: Visit 01:Screening and enrollment (Day -1) Visit 02: Primary end point & end of study visit (Day 28) | — |
Countries
India
Contacts
Public ContactDr Suman G
RAJALAKSHMI HOSPITAL
Outcome results
None listed