An Exploratory Study to Determine Bioavailability and Transferrin Saturation Following a Single Dose of a Novel Iron Supplement (IHAT) in Gambian Women.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Relative bioavailability value of IHAT versus ferrous sulphate
研究概览
简要总结
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.
详细描述
The study's main hypothesis is that IHAT will be bioavailable in pre-menopausal anaemic Gambian women and will lead to a lower serum iron and transferrin saturation increase than an equivalent dose of ferrous sulphate. Furthermore, the investigators hypothesize that IHAT will produce a less harmful post-ingestion rise in transferrin saturation, i.e. the serum collected from subjects following a single dose of IHAT will promote less pathogen growth in ex vivo assays than that collected following an equivalent dose of ferrous sulphate. Finally, based on previous animal data [5], the investigators hypothesize that IHAT absorption will be significantly higher in anaemic women compared to non-anaemic women, and that this will not be the case with ferrous sulphate.
This study is a cross-over, single-dose comparison against ferrous sulphate (standard of care) in anaemic and non-anaemic women. The iron single dosage for both compounds will be 60mg elemental iron equivalent and each compound will be labelled with a stable iron isotope. Outcomes will be: red blood cell incorporation of labelled iron, serum iron, transferrin saturation and pathogen growth in ex vivo serum assays.
Primary objective:
To determine iron bioavailability (i.e. red blood cell incorporation) from a single dose of IHAT versus ferrous sulphate in pre-menopausal Gambian women.
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Malaria and other infections
- •Severe anaemia (Hb<9 g/dL)
- •CRP> 5 mg/L
- •Chronic disease
- •Currently participating in other iron intervention studies.
研究组 & 干预措施
Iron deficient anaemic (IDA): IHAT new manufacture
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.
干预措施: Ferrous sulphate (Dietary Supplement)
Iron deficient anaemic (IDA): IHAT new manufacture
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.
干预措施: IHAT (Dietary Supplement)
Iron sufficient: non-IDA
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.
干预措施: Ferrous sulphate (Dietary Supplement)
Iron sufficient: non-IDA
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.
干预措施: IHAT (Dietary Supplement)
Iron deficient anaemic: IDA
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.
干预措施: Ferrous sulphate (Dietary Supplement)
Iron deficient anaemic: IDA
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.
干预措施: IHAT (Dietary Supplement)
结局指标
主要结局
Relative bioavailability value of IHAT versus ferrous sulphate
时间窗: 14 days
This will be determined from the red blood cell incorporation of isotope-labelled iron 14 days following a single oral dose.
次要结局
- Serum iron(6 hours)
- Pathogen Growth(6 hours)
- Plasma iron(6 hours)
- Transferrin saturation(6 hours)
研究者
dora pereira
Senior Investigator Scientist
Medical Research Council