Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients
NCT ID: NCT05791591
Last Updated: 2024-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
168 participants
INTERVENTIONAL
2023-04-15
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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NUV001 - IR
Sickle cell disease patients receiving NUV001 Immediate release gel capsule formulation
NUV001 - IR
Daily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total
NUV001 - GR
Sickle cell disease patients receiving NUV001 Gastro resistant gel capsule formulation
NUV001 - GR
Daily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total
Placebo
Sickle cell disease patients receiving Placebo
Placebo
Placebo containing starch Powder (1000 mg, daily in two administration orally for 90 days)
Interventions
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NUV001 - IR
Daily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total
NUV001 - GR
Daily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total
Placebo
Placebo containing starch Powder (1000 mg, daily in two administration orally for 90 days)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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ProRelix Research
INDUSTRY
LGD
INDUSTRY
Responsible Party
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Principal Investigators
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Matthias Canault, PhD
Role: STUDY_DIRECTOR
LGD
Locations
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Aman Hospital and Research Center
Vadodara, Gujarat, India
Kingsway Hospital
Nagpur, Maharashtra, India
Sai Krupa Hospital & Research Centre
Ahmedabad, , India
Thalassemia & Sickle Cell Society
Hyderabad, , India
Index Medical College
Indore, , India
NRSMC Hospital
Kolkata, , India
Arihant Hospital
Nagpur, , India
Shalinitai Meghe Hospital & Research Centre
Nagpur, , India
Countries
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Other Identifiers
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LGD-CLI-006
Identifier Type: OTHER
Identifier Source: secondary_id
LGD-NUV001-CT01-22
Identifier Type: -
Identifier Source: org_study_id
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