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

RDC Clinical

Status and phase

Completed

Phase 3

Conditions

Iron-deficiency

Treatments

Drug: High Dose IHAT

Drug: Low dose IHAT

Drug: Carob flour

Study type

Interventional

Funder types

Industry

Identifiers

NCT05950841

IHATID

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Generally healthy iron deficient pre-menopausal women
Iron deficiency defined as Serum ferritin < 30 ug/L (1)
Generally healthy defined as C-reactive protein < 3 mg/L (1)
Subjects adhering to a vegetarian or vegan diet are allowed
Agree not to give blood donations during the study
Able to provide informed consent
Agree not to participate in another clinical trial while enrolled in this trial
Agree not to change current diet and/or exercise frequency or intensity

Exclusion criteria

Anaemia (as determined from the haematocrit and haemoglobin measures) (2)
Previously told they have an iron absorption problem
Subjects regularly taking iron specific supplements during or 2 months prior to study commencement (the use of other mineral/vitamin/herbal preparations is allowed but should be recorded) (3)
Any uncontrolled serious illness (4)
Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
Active smokers, nicotine use, alcohol(5) or drug (prescription or illegal substances) abuse
Chronic gastrointestinal disorders
Pregnant/lactating women or women trying to conceive
Diagnosed depression or mental disorder that is uncontrolled
Eating disorders
BMI > 35 kg/m2
Allergic to any of the ingredients in active or placebo formula
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Participants who have participated in any other clinical trial during the past 1 month

Footnotes

A blood test is required prior to enrolment into the study to receive trial product. Participants will be required to attend a local pathology collection centre and have serum ferritin and CRP within the required limits to be considered enrolled in the study and be provided with trial product.
Anyone considered to be anaemic will be excluded and directed to their GP. In women, anaemia is defined as any of the following: Haemoglobin < 115 g/L, Haematocrit < 35%.
Potential participants that are taking supplements that would result in their exclusion must wait an 8-week washout period prior to commencing the study.
An uncontrolled illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
Chronic past and/or current alcohol use (>14 alcohol drinks/week).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 3 patient groups, including a placebo group

Low dose IHAT

Experimental group

Description:

IHAT in capsule form and carob flour in capsule form - taken as 1 x 100mg IHAT capsule (equiv 30mg iron) in the morning with water and 1 x placebo capsule in the evening with water

Treatment:

Drug: Low dose IHAT

High dose IHAT

Experimental group

Description:

IHAT in capsule form - taken as 2 x 100mg (equiv 60mg iron) daily with water (1 in the morning and 1 in the evening)

Treatment:

Drug: High Dose IHAT

Carob flour

Placebo Comparator group

Description:

Carob flour in capsule form - taken as 2 x capsules daily with water (1 in the morning and 1 in the evening)