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Effect of NUV001 Supplementation in Patients Suffering From Sickle Cell Disease (SCD)

NCT05789355 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-05-28

No results posted yet for this study

Summary

This is a pilot study of daily dosing of NUV001 as a dietary supplement in 12 sickle cell disease patients with 3 months of follow-up plus 1 month after supplementation.The present study is designed to evaluate, first, the safety and tolerability parameters as well as to measure the plasma and urinary residues of daily oral doses of NUV001. Secondly, the study will evaluate the impact of NUV001 on biological parameters and quality of life of patients.

Conditions

Interventions

DIETARY_SUPPLEMENT

NUV001

Daily supplementation with NUV001 at 1000 mg (4 tablets of 250 mg each) for 90 days with a prolonged follow-up of 1 month (30 days) after stopping the supplementation

Sponsors & Collaborators

  • CEN Biotech

    collaborator INDUSTRY

  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER

  • Etablissement Français du Sang

    collaborator OTHER

  • LGD

    lead INDUSTRY

Principal Investigators

  • Laurent LAGANIER · LGD SARL

  • Estelle JEAN-MIGNARD · Assistance Publique Hopitaux Marseille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-05-10
Completion
2024-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789355 on ClinicalTrials.gov