Could a simple supplement ease sickle cell symptoms?
NCT ID NCT05791591
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a nutraceutical supplement called NUV001 in 168 adults with sickle cell disease. Participants took either an immediate-release or gastro-resistant version of NUV001, or a placebo, daily for 90 days. The main goal was to check safety and tolerability, with early looks at blood markers and patient-reported outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NUV001 (a nutraceutical supplement)
- What this could lead to
- If it works, this could point toward a safe, daily supplement to help manage sickle cell disease symptoms alongside standard care.
- What could go wrong
- This is a small, early pilot study focused on safety, not proof of effectiveness. The supplement may show no benefit over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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168 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jul 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 65 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: 1. Men or women over 18 to 65 years, both inclusive. 2. Non-smokers. 3. BMI \> 18 kg/m2 4. Patients diagnosed with sickle cell disease (documented by haemoglobin electrophoresis) and carrying SS or Sbeta0 versions of the beta globin gene (documented by genotyping, known through medical history). 5. Haemoglobin levels between 5.5 and 10.5 g/dl during Screening (for newly diagnosed or patients not on any treatment for SCD). 6. If the patient has been treated with an anti-sickling agent within three months of the Screening visit, the therapy must have been continuous for at least three months with the intent to continue for the duration of the study. 7. Available to attend on an outpatient basis for visits provided for in the protocol and able to complete the data collection documents (compliance and quality of life scale) 8. Patient or the patient's legally authorized representative has given written informed consent. Exclusion Criteria: 1. Patients with known or suspected allergy to any ingredient of the food supplement 2. Patient having consumed vitamin or food supplements containing NAD+ precursors (niacin, tryptophan, nicotinamide, NMN, NR etc...) during the month before selection. 3. Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit. 4. Patient has prothrombin time INR \> 2.0. 5. Patient has serum albumin less than 3.0 g/dl. 6. Patient has received any blood products within three months of the Screening visit. 7. Patients hospitalized for acute vaso-occlusive crisis within one month of the Screening visit. 8. Patient has clinically significant, cardiovascular or liver disease or renal insufficiency or lymphopenia , evident in medical history (with clinically significant abnormal results on the Screening bioassays for eg.: Complete blood count, Aspartate transaminases, Alanine transaminases, Gamma glutamyl transferase, Alkaline Phosphatase, Bilirubin, Creatinine, Creatinine Phosphokinase, Blood Glucose, HbA1c, Lipid Profile). 9. Patient with diagnosed cancer in the past 2 years. 10. Patients participating simultaneously in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed. 11. Pregnant, lactating or parturient women. 12. Persons deprived of their liberty by a judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than that of research. 13. Majors under legal protection or unable to express their consent. 14. People in an emergency situation unable to express their prior consent.
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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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Aman Hospital and Research Center
Vadodara, Gujarat, Vadodara-390021, India
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Arihant Multispeciality Hospital
Nagpur, India
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Index Medical College
Indore, India
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Kingsway Hospital
Nagpur, Maharashtra, Nagpur-440001, India
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NRSMC Hospital
Kolkata, India
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Sai Krupa Hospital & Research Centre
Ahmedabad, India
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Shalinitai Meghe Hospital & Research Centre
Nagpur, India
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Shivam Hospital
Ahmedabad, 380008, India
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Thalassemia & Sickle Cell Society
Hyderabad, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding common pain drugs reduce morphine needs in sickle cell crises?
- Gene editing offers hope for a One-Time sickle cell cure
- Tiny biochip could reveal sickle cell severity
- Can a milder transplant cure sickle cell and thalassemia in adults?
- Can an antioxidant supplement calm sickle cell blood cells?
- Can a softer transplant cure sickle cell disease?