Sickle Cell DiseaseNCT05791591
Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients
A study testing NUV001 - IR and NUV001 - GR in people with Sickle Cell Disease, run by LGD at 9 sites in India.
Trial summary
This multicenter, randomized, double-blind, parallel-group, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of orally administered NUV001 in adult participants with sickle cell disease (HbSS or HbSβ0 genotypes). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- NUV001 - IR and NUV001 - GR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 9 sitesIndia
- Study dates
- 16 Apr 2023to 3 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women over 18 to 65 years, both inclusive.
- Non-smokers.
- BMI > 18 kg/m2
- 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).
- Haemoglobin levels between 5.5 and 10.5 g/dl during Screening (for newly diagnosed or patients not on any treatment for SCD).
- 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.
- 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)
- Patient or the patient's legally authorized representative has given written informed consent.
Who cannot join
- Patients with known or suspected allergy to any ingredient of the food supplement
- Patient having consumed vitamin or food supplements containing NAD+ precursors (niacin, tryptophan, nicotinamide, NMN, NR etc...) 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 prothrombin time INR > 2.0.
- Patient has serum albumin less than 3.0 g/dl.
- Patient has received any blood products within three months of the Screening visit.
Show all 14Show fewer
- Patients hospitalized for acute vaso-occlusive crisis within one month of the Screening visit.
- 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).
- Patient with diagnosed cancer in the past 2 years.
- Patients participating simultaneously in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.
- Pregnant, lactating or parturient women.
- 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.
- Majors under legal protection or unable to express their consent.
- People in an emergency situation unable to express their prior consent.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Shivam Hospital
Ahmedabad, 380008
Sai Krupa Hospital & Research Centre
Ahmedabad
Thalassemia & Sickle Cell Society
Hyderabad
Index Medical College
Indore
NRSMC Hospital
Kolkata
Kingsway Hospital
Nagpur, Maharashtra, Nagpur-440001
Arihant Multispeciality Hospital
Nagpur
Shalinitai Meghe Hospital & Research Centre
Nagpur
Aman Hospital and Research Center
Vadodara, Gujarat, Vadodara-390021
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients.
This multicenter, randomized, double-blind, parallel-group, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of orally administered NUV001 in adult participants with sickle cell disease (HbSS or HbSβ0 genotypes). A total of 168 participants were randomized in a 1:1:1 ratio to receive NUV001 immediate-release (IR), NUV001 gastro-resistant (GR), or placebo, in addition to standard of care, for 90 days over 5 study visits. The primary objective was to assess safety and tolerability based on adverse events, clinical laboratory safety parameters, and vital signs. Exploratory secondary objectives evaluated hematologic, hemolysis, and patient-reported outcomes.
Read the detailed description
This was a multicenter, randomized, double-blind, parallel-group, placebo-controlled pilot study conducted in adult participants with sickle cell disease.
Participants were randomized in a 1:1:1 ratio to one of three treatment groups:
- NUV001 immediate-release (IR)
- NUV001 gastro-resistant (GR)
- Matching placebo
All treatments were administered orally in addition to standard of care for 90 days.
The study was designed to evaluate safety and tolerability, including adverse events, clinical laboratory safety parameters, and vital signs. Exploratory objectives included evaluation of hematologic parameters, markers of hemolysis, and patient-reported outcomes related to pain and quality of life.
The study was conducted as a pilot, feasibility, and design-informing clinical study.
- Conditions
- Sickle Cell Disease
- Being tested
- NUV001 - IR, NUV001 - GR, Placebo
- Keywords
- Hb-SS, Hb S/β0-Thal
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUV001 - IRDietary supplement
Daily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total.
NUV001 - GRDietary supplement
Daily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total.
PlaceboDietary supplement
Placebo containing starch Powder (1000 mg, daily in two administration orally for 90 days).
| Study group | Role | What they receive |
|---|---|---|
| NUV001 Immediate-Release (IR) | Experimental | Participants received oral NUV001 immediate-release formulation at a total daily dose of 1000 mg for 90 days, in addition to standard of care. Receives: Dietary Supplement: NUV001 - IR |
| NUV001 Gastro-Resistant (GR) | Experimental | Participants received oral NUV001 gastro-resistant formulation at a total daily dose of 1000 mg for 90 days, in addition to standard of care. Receives: Dietary Supplement: NUV001 - GR |
| Placebo | Placebo comparator | Participants received matching placebo for 90 days, in addition to standard of care. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events through Day 90.
Subject incidence of treatment-emergent adverse events through the treatment period.
Measured: Baseline to Day 90
Change from baseline in hematologic and biochemical safety parameters at Day 90.
Change from baseline to Day 90 in complete blood count, blood glucose, calcium, electrolytes, total protein, albumin, alkaline phosphatase, bilirubin, blood urea nitrogen, creatinine, AST, ALT, and estimated glomerular filtration rate (eGFR).
Measured: Baseline and Day 90
Change from baseline in vital signs at Day 90.
Change from baseline to Day 90 in systolic and diastolic blood pressure, pulse rate, respiration rate, and body temperature.
Measured: Baseline and Day 90.
Secondary outcomes (11)
Change in percentage of HbF-positive cells.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in HbF content in Red Blood Cells.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in percentage of circulating irreversibly sickled cells.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in hematocrit.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in indirect bilirubin level.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in reticulocyte count.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in serum lactate dehydrogenase level.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in ASCQ-Me Questionnaire (Adult Sickle Cell Quality of Life Measurement Information System)
Questionnaire on acute and/or chronic pain, energy level, usage of pain medications and activity levels.
Measured: Baseline, Day 30, Day 60, Day 90.
Change in pain intensity score.
Evaluation of pain intensity for each body location (using a numeric pain rating scale from 0, no pain to 10 worst possible pain)
Measured: Baseline, Day 30, Day 60, Day 90.
Change in pain relief score.
Evaluation and evaluation of pain relief (pain relief scale in percent from 0%, no relief to 100% complete relief)
Measured: Baseline, Day 30, Day 60, Day 90.
Occurrence of vaso-occlusive crises during the study
Measured: Day 0 to Day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start16 Apr 2023
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- LGD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProRelix Research, Nuvamid SA
- Responsible party
- Sponsor
- Investigators
- Matthias CANAULT, PhD, Study director, LGD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791591
- Sponsor's protocol ID
- LGD-NUV001-CT01-22
- Other IDs
- LGD-CLI-006
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients.
- ClinicalTrials.gov ID
- NCT05791591
- Acronym / sponsor ID
- LGD-NUV001-CT01-22
- Conditions
- Sickle Cell Disease
- Keywords
- Hb-SS, Hb S/β0-Thal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- LGDIndustry (pharma, biotech, devices)
- Collaborators
- ProRelix Research, Nuvamid SA
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind, parallel-group, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of orally administered NUV001 in adult participants with sickle cell disease (HbSS or HbSβ0 genotypes). A total of 168 participants were randomized in a 1:1:1 ratio to receive NUV001 immediate-release (IR), NUV001 gastro-resistant (GR), or placebo, in addition to standard of care, for 90 days over 5 study visits. The primary objective was to assess safety and tolerability based on adverse events, clinical laboratory safety parameters, and vital signs. Exploratory secondary objectives evaluated hematologic, hemolysis, and patient-reported outcomes.
Detailed description
This was a multicenter, randomized, double-blind, parallel-group, placebo-controlled pilot study conducted in adult participants with sickle cell disease.
Participants were randomized in a 1:1:1 ratio to one of three treatment groups:
- NUV001 immediate-release (IR)
- NUV001 gastro-resistant (GR)
- Matching placebo
All treatments were administered orally in addition to standard of care for 90 days.
The study was designed to evaluate safety and tolerability, including adverse events, clinical laboratory safety parameters, and vital signs. Exploratory objectives included evaluation of hematologic parameters, markers of hemolysis, and patient-reported outcomes related to pain and quality of life.
The study was conducted as a pilot, feasibility, and design-informing clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NUV001 Immediate-Release (IR) | Experimental | Dietary Supplement: NUV001 - IRParticipants received oral NUV001 immediate-release formulation at a total daily dose of 1000 mg for 90 days, in addition to standard of care. |
| NUV001 Gastro-Resistant (GR) | Experimental | Dietary Supplement: NUV001 - GRParticipants received oral NUV001 gastro-resistant formulation at a total daily dose of 1000 mg for 90 days, in addition to standard of care. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants received matching placebo for 90 days, in addition to standard of care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women over 18 to 65 years, both inclusive.
- Non-smokers.
- BMI > 18 kg/m2
- 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).
- Haemoglobin levels between 5.5 and 10.5 g/dl during Screening (for newly diagnosed or patients not on any treatment for SCD).
Key exclusion criteria (14 listed)
- Patients with known or suspected allergy to any ingredient of the food supplement
- Patient having consumed vitamin or food supplements containing NAD+ precursors (niacin, tryptophan, nicotinamide, NMN, NR etc...) 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 prothrombin time INR > 2.0.
- Patient has serum albumin less than 3.0 g/dl.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUV001 - IRDaily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total. | Dietary supplement | NUV001 Immediate-Release (IR) |
| NUV001 - GRDaily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total. | Dietary supplement | NUV001 Gastro-Resistant (GR) |
| PlaceboPlacebo containing starch Powder (1000 mg, daily in two administration orally for 90 days). | Dietary supplement | Placebo |
Primary outcome
Incidence of adverse events through Day 90.
Time frame: Baseline to Day 90
Subject incidence of treatment-emergent adverse events through the treatment period.
Change from baseline in hematologic and biochemical safety parameters at Day 90.
Time frame: Baseline and Day 90
Change from baseline to Day 90 in complete blood count, blood glucose, calcium, electrolytes, total protein, albumin, alkaline phosphatase, bilirubin, blood urea nitrogen, creatinine, AST, ALT, and estimated glomerular filtration rate (eGFR).
Change from baseline in vital signs at Day 90.
Time frame: Baseline and Day 90.
Change from baseline to Day 90 in systolic and diastolic blood pressure, pulse rate, respiration rate, and body temperature.
11 secondary outcomes
Change in percentage of HbF-positive cells.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in HbF content in Red Blood Cells.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in percentage of circulating irreversibly sickled cells.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in hematocrit.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in indirect bilirubin level.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in reticulocyte count.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in serum lactate dehydrogenase level.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in ASCQ-Me Questionnaire (Adult Sickle Cell Quality of Life Measurement Information System)
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in pain intensity score.
Time frame: Baseline, Day 30, Day 60, Day 90.
Change in pain relief score.
Time frame: Baseline, Day 30, Day 60, Day 90.
Occurrence of vaso-occlusive crises during the study
Time frame: Day 0 to Day 90.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias CANAULT, PhD study director
LGD
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUV001 - IR and NUV001 - GR in people with Sickle Cell Disease, run by LGD at 9 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events through Day 90. (time frame: Baseline to Day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.