IHAT Absorption Kinetics

NCT02498886 | Completed Early Phase 1

• 1 other identifier: 1422
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron-deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (4)

• Serum iron

  6 hours

• Transferrin saturation

  6 hours

• Pathogen Growth

  6 hours

• Plasma iron

  6 hours

Study Arms (3)

Iron deficient anaemic: IDA

EXPERIMENTAL

Iron deficient anaemic women. Interventions: two iron supplements will be used: IHAT- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent. Each compound will be labelled with a stable isotope of iron: IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe. 1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart.

Dietary Supplement: IHAT; Dietary Supplement: Ferrous sulphate

Iron sufficient: non-IDA

EXPERIMENTAL

Women that are not anaemic or iron deficient. Interventions: two iron supplements will be used: IHAT- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent. Each compound will be labelled with a stable isotope of iron: IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe. 1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart.

Dietary Supplement: IHAT; Dietary Supplement: Ferrous sulphate

Iron deficient anaemic (IDA): IHAT new manufacture

EXPERIMENTAL

Iron deficient anaemic women. Interventions: two iron supplements will be used: IHAT new manufacture- iron hydroxide adipate tartrate: an analogue of natural food iron. Ferrous sulphate- the gold standard for iron supplementation. For both the iron single-dose will be 60mg elemental iron equivalent. Each compound will be labelled with a stable isotope of iron: IHAT with 2 mg 58Fe and ferrous sulphate with 10 mg 57Fe. 1 capsule of each compound will be ingested with a full glass of water in two separate occasions, 14 days apart.

Dietary Supplement: IHAT; Dietary Supplement: Ferrous sulphate

Interventions

IHAT DIETARY_SUPPLEMENT

Iron hydroxide adipate tartrate (IHAT): Single dose capsule containing IHAT equivalent to 60mg iron with 2 mg isotopically enriched with 58Fe.

Iron deficient anaemic (IDA): IHAT new manufacture; Iron deficient anaemic: IDA; Iron sufficient: non-IDA

Ferrous sulphate DIETARY_SUPPLEMENT

Ferrous sulphate: Single dose capsule containing ferrous sulphate heptahydrate equivalent to 60 mg iron with 10 mg isotopically enriched with 57Fe.

Iron deficient anaemic (IDA): IHAT new manufacture; Iron deficient anaemic: IDA; Iron sufficient: non-IDA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal women apparently healthy (as judged by a study nurse at the screening day) with normal CRP (measured at screening).
• Non-pregnant (will be tested with a rapid pregnancy test) and non-lactating women.
• IDA arm: 9≤Hb≤11 g/dL and ferritin≤ 15 ng/ml
• Non-IDA arm: Hb\>11 g/dL and ferritin\> 15 ng/ml.

You may not qualify if:

• Malaria and other infections
• Severe anaemia (Hb\<9 g/dL)
• CRP\> 5 mg/L
• Chronic disease
• Currently participating in other iron intervention studies.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

MRC Unit The Gambia

Keneba, West Kiang, The Gambia

Location

Related Publications (3)

• Pereira DI, Bruggraber SF, Faria N, Poots LK, Tagmount MA, Aslam MF, Frazer DM, Vulpe CD, Anderson GJ, Powell JJ. Nanoparticulate iron(III) oxo-hydroxide delivers safe iron that is well absorbed and utilised in humans. Nanomedicine. 2014 Nov;10(8):1877-86. doi: 10.1016/j.nano.2014.06.012. Epub 2014 Jun 28.

  PMID: 24983890 BACKGROUND

• Powell JJ, Bruggraber SF, Faria N, Poots LK, Hondow N, Pennycook TJ, Latunde-Dada GO, Simpson RJ, Brown AP, Pereira DI. A nano-disperse ferritin-core mimetic that efficiently corrects anemia without luminal iron redox activity. Nanomedicine. 2014 Oct;10(7):1529-38. doi: 10.1016/j.nano.2013.12.011. Epub 2014 Jan 4.

  PMID: 24394211 BACKGROUND

• Aslam MF, Frazer DM, Faria N, Bruggraber SF, Wilkins SJ, Mirciov C, Powell JJ, Anderson GJ, Pereira DI. Ferroportin mediates the intestinal absorption of iron from a nanoparticulate ferritin core mimetic in mice. FASEB J. 2014 Aug;28(8):3671-8. doi: 10.1096/fj.14-251520. Epub 2014 Apr 28.

  PMID: 24776745 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dora I Pereira, PhD

  Medical Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator Scientist

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

TH (1)