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COMPLETED
NCT05791591
NA

Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients

Sponsor: LGD

View on ClinicalTrials.gov

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). 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.

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2023-04-16

Completion Date

2024-07-03

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

NUV001 - IR

Daily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total.

DIETARY_SUPPLEMENT

NUV001 - GR

Daily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total.

DIETARY_SUPPLEMENT

Placebo

Placebo containing starch Powder (1000 mg, daily in two administration orally for 90 days).

Locations (9)

Aman Hospital and Research Center

Vadodara, Gujarat, India

Kingsway Hospital

Nagpur, Maharashtra, India

Shivam Hospital

Ahmedabad, India

Sai Krupa Hospital & Research Centre

Ahmedabad, India

Thalassemia & Sickle Cell Society

Hyderabad, India

Index Medical College

Indore, India

NRSMC Hospital

Kolkata, India

Arihant Multispeciality Hospital

Nagpur, India

Shalinitai Meghe Hospital & Research Centre

Nagpur, India