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Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women

NCT06285799 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-06-04

No results posted yet for this study

Summary

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels 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 IHAT capsule (100mg IHAT per capsule) and once daily dose of 1 placebo capsule (carob flour)

DRUG

High Dose IHAT

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

DRUG

Carob Flour

Twice daily dose of 1 placebo capsule (carob flour)

Sponsors & Collaborators

  • RDC Clinical Pty Ltd

    collaborator INDUSTRY

  • Nemysis Ltd

    lead INDUSTRY

Principal Investigators

  • Maria Cristina Comelli, PhD · Nemysis Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2025-02-11
Completion
2025-02-15

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 NCT06285799 on ClinicalTrials.gov