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Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman

NCT05950841 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-10

No results posted yet for this study

Summary

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in iron-deficient but otherwise healthy premenopausal women over 12 weeks.

Conditions

  • Iron-deficiency

Interventions

DRUG

Low dose IHAT

Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)

DRUG

High Dose IHAT

Twice daily dose of 1 capsule (100mg per capsule IHAT)

DRUG

Carob flour

Twice daily dose of 1 capsule (carob flour)

Sponsors & Collaborators

  • Nemysis Ltd

    collaborator INDUSTRY

  • RDC Clinical Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Amanda Rao, PhD · RDC Clinical Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2025-02-03
Completion
2025-02-03

Countries

  • Australia

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 NCT05950841 on ClinicalTrials.gov