New supplement shows promise for sickle cell sufferers in early trial
NCT ID NCT05789355
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a daily dietary supplement called NUV001 in 12 adults with sickle cell disease (SS type) over 120 days. The main goals were to see if it is safe and tolerable, and to measure its effects on blood health and quality of life. Researchers tracked side effects, hospital visits, and changes in lab results to understand how the supplement might help manage the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Participants meeting the following criteria could be included: * Male or female between 18 and 60 years old. * Females of childbearing potential should be using one of the following acceptable methods of birth control: * Intrauterine Device in place for at least 60 days prior to the first dose of the study (Visit 1) 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 (Visit 1) throughout the study, and for 30 days after study completion. * Patients whose weight is greater than 50 kg. * Patients diagnosed with homozygous sickle cell anemia of SS genotype (documented by genotyping). * Patients who have been treated with an anti-sickling agent (Siklos®) within six months of the screening visit (Visit 0) must maintain the therapy continuous and unmodified for at least six months with the intent to continue for the duration of the study. * Patients who are available to attend on an outpatient basis for visits provided for in the protocol and can complete the data collection documents (and quality of life scale). * Patients have given written informed consent. * Patients with a health insurance coverage. Exclusion criteria: * Participants meeting the following criteria could not be included: * Patients with known or suspected allergies to any ingredient of the food supplement (β-NMN, Isomalt, Magnesium stearate, microcrystalline cellulose). * Patients who have consumed food supplements containing tryptophan, glutamine or vitamin B3 in various forms (nicotinic acid/niacin and nicotinamide) during the month before selection. * Patients have a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit (Visit 0). * Patients have serum albumin \< 3.0 g/dl (\< 30 g/L). * Patients have been transfused and received any blood products within three months of the Screening Visit (Visit 0). * Patients have been hospitalized for acute vaso-occlusive crisis within one month of the Screening Visit (Visit 0). * Patient has clinically significant cardiovascular or liver disease, renal or lung insufficiency or lymphopenia (with clinically significant abnormal results on the screening bioassays: CBC, transaminases (AST, ALT, GGT, ALP), bilirubin, creatinine, CPK, ionogram, blood glucose, lipid profile). * Patients with a diagnosed cancer in the past 2 years. * Pregnant or lactating woman. Women of childbearing potential should have a negative serum or urine pregnancy test at screening and a negative urine pregnancy test at inclusion prior to administration of the study product.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aphm Hopital La Timone Adultes Sce Medecine Interne (Umap)
Marseille, 13005, France
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Other studies related to the condition(s) this trial covers.
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