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Safety and Efficacy of the Combination Therapy of Fucoidan / Fucoxanthin / L-carnitine in Patients With Diabetic Nephropathy.

NCT07804641 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-09-04

No results posted yet for this study

Summary

The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of fucoidan/fucoxanthin/L-carnitine combinaed therapy in patients with diabetic kidney disease.

Participants were randomly assigned in a 1:1 ratio to either the Treatment Group or the Control Group. The primary objective is to investigate whether fucoidan/fucoxanthin/L-carnitine/Zinc yeast combinaed therapy can significantly improve albuminuria or renal function after a treatment period of 12 weeks. Secondary outcomes include evaluating the safety profile and potential side effects of the intervention.

It is hypothesized that the intervention will show a beneficial effect on albuminuria compared to the control group. in patients withdiabetic kidney disease.

Conditions

  • Diabetic Kidney Disease (DKD)

Interventions

DIETARY_SUPPLEMENT

Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL)

Combined marine-derived formulation administered orally in capsule form. Each day, participants took 4 capsules, providing a total daily dose of 740 mg of low-molecular-weight oligo-fucoidan, 1200 mg of fucoxanthin-containing extract, and 120 mg of L-carnitine. The intervention was used as an add-on therapy to standard diabetic kidney disease care for a total duration of 12 weeks.

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2025-11-05
Completion
2026-03-11

Countries

  • Taiwan

Study Locations

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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 NCT07804641 on ClinicalTrials.gov