NCT02498886

An Exploratory Study to Determine Bioavailability and Transferrin Saturation Following a Single Dose of a Novel Iron Supplement (IHAT) in Gambian Women.

Completed EARLY_PHASE1 Last updated 3 February 2017

What this trial tests

EARLY_PHASE1 trial testing IHAT in Iron-deficiency Anemia in 34 participants. Completed in 1 March 2016.

Timeline

1 August 2015

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Medical Research Council
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	34
Start date	1 August 2015
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	1 location across The Gambia

Drugs / interventions tested

• IHAT
• Ferrous sulphate — full drug profile →

Conditions studied

• Iron-deficiency Anemia — all drugs for Iron-deficiency Anemia →

Sponsor

Medical Research Council

Who can join

Adults 18 to 45, female only, with Iron-deficiency Anemia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Relative bioavailability value of IHAT versus ferrous sulphate
  Time frame: 14 days
  This will be determined from the red blood cell incorporation of isotope-labelled iron 14 days following a single oral dose.

Sponsor's own description

At MRC Human Nutrition Research, the investigators have developed an engineered analogue of the ferritin-core for safe and effective iron supplementation. Iron hydroxide adipate tartrate (IHAT) is a tartrate-modified, nano-disperse Fe(III) oxo-hydroxide, formed in an adipate buffer, with similar functional properties and small primary particle size (\~2 nm) as the iron found in the ferritin core; it better mimics iron absorption from food than the non-physiological bolus doses of ferrous sulphate currently used.

This exploratory study will test the hypothesis that IHAT has equivalent bioavailability to ferrous sulphate but produces a less harmful post-ingestion rise in transferrin saturation. The design is a 3-arm (IDA, non-IDA and IDA-IHAT new manufacture), crossover, randomised, single-dose study.

Primary endpoint:

Relative bioavailability value of IHAT versus ferrous sulphate. This will be determined from the red blood cell incorporation of isotope-labelled iron 14 days following a single oral dose.

Secondary endpoints:

Serum iron at 0, 2, 4, 6 hours following a single dose of each iron compound. Transferrin saturation at 0, 2, 4, 6 hours following a single dose of each iron compound.

Plasma 58Fe and 57Fe at 0, 2, 4, 6 hours. Pathogen growth using ex vivo assays in serum collected from each subject at 0, 2, 4 and 6 hours following a single dose.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.