Effect of NUV001 Supplementation in Patients Suffering From Sickle Cell Disease (SCD)
Sickle Cell Disease
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring safety, tolerance, SS genotype of sickle cell disease
Eligibility Criteria
Inclusion Criteria: Man or woman comprised between 18 and 60 years old. Patients diagnosed with homozygous sickle cell anemia of SS genotype (documented by genotyping). Females of childbearing potential should be using one of the following acceptable methods of birth control: Intrauterine Device (IUD) in place for at least 60 days prior to the first dose of the study throughout the study and for 30 days after completion of the study. Hormonal contraceptives for at least 90 days prior to the first dose of the study throughout the study, and for 30 days after study completion. Patients whose weight is greater than 50 kg. Patient that has been treated with an anti-sickling agent (Hydroxyurea) within six months of the screening visit, must maintain the therapy continuous and unmodified for at least six months with the intent to continue for the duration of the study. Patient available to attend on an outpatient basis for visits provided for in the protocol and able to complete the data collection documents (and quality of life scale). Patient has given written informed consent. Patient with health insurance scheme Exclusion Criteria: Patient with known or suspected allergy to any ingredient of the food supplement . Patient having consumed food supplements containing tryptophan, glutamine or vitamin B3 in its various forms (nicotinic acid/niacin and nicotinamide) during the month before selection Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit. Patient has serum albumin < 3.0 g/dl. Patient has been transfused and received any blood products within three months of the Screening Visit. Patient has been hospitalized for acute vaso-occlusive crisis within one months of the Screening Visit. Patient has clinically significant, cardiovascular or liver disease, renal or lung insufficiency or lymphopenia (with clinically significant abnormal results on the screening bioassays: complete blood count, transaminases (ASAT, ALAT, GGT, ALP), bilirubin, creatinine, CPK, Ionogram, blood glucose, lipid profile). Patients with diagnosed cancer in the past 2 years Pregnant or lactating woman. Woman of childbearing potential should have a negative (serum or urinary TBD) pregnancy test at screening and a negative urine pregnancy test at inclusion prior to administration of the Study Product.
Sites / Locations
- Aphm Hopital La Timone Adultes Sce Medecine Interne (Umap)Recruiting
Arms of the Study
Arm 1
Experimental
NUV001
Daily supplementation with NUV001 1000 mg