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Could a simple supplement ease sickle cell symptoms?

NCT ID NCT05791591

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

168 people

The number who actually took part.

Started

Apr 2023

Finished

Jul 2024

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Aman Hospital and Research Center

    Vadodara, Gujarat, Vadodara-390021, India

  • Arihant Multispeciality Hospital

    Nagpur, India

  • Index Medical College

    Indore, India

  • Kingsway Hospital

    Nagpur, Maharashtra, Nagpur-440001, India

  • NRSMC Hospital

    Kolkata, India

  • Sai Krupa Hospital & Research Centre

    Ahmedabad, India

  • Shalinitai Meghe Hospital & Research Centre

    Nagpur, India

  • Shivam Hospital

    Ahmedabad, 380008, India

  • Thalassemia & Sickle Cell Society

    Hyderabad, India

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Other studies related to the condition(s) this trial covers.