NCT05950841

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

A Randomised, Double-blind Study to Determine the Safety and Efficacy of IHAT in Iron Deficient Premenopausal Women.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: RDC Clinical Pty Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2024-03-06
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2023-07-18
• Last updated: 2025-03-10

Locations

1 site across 1 country: Australia