NCT05950841已完成3 期
A Randomised, Double-blind Study to Determine the Safety and Efficacy of IHAT in Iron Deficient Premenopausal Women.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Percentage of women recovering from ID at week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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).
研究组 & 干预措施
Low dose IHAT
Experimental
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
干预措施: Low dose IHAT (Drug)
High dose IHAT
Experimental
IHAT in capsule form - taken as 2 x 100mg (equiv 60mg iron) daily with water (1 in the morning and 1 in the evening)
干预措施: High Dose IHAT (Drug)
Carob flour
Placebo Comparator
Carob flour in capsule form - taken as 2 x capsules daily with water (1 in the morning and 1 in the evening)
干预措施: Carob flour (Drug)
结局指标
主要结局
Percentage of women recovering from ID at week 12
时间窗: Week 12
Percentage of women recovering from ID at week 12, defined as serum ferritin levels of 30 -150 ug/L
次要结局
- Time to reach normalisation of ferritin levels(Baseline, week 6 and week 12)
- Iron Status(Baseline, week 6 and week 12)
- Incidence and prevalence of gastrointestinal side effects(Baseline, weeks 1 - 5, week 6 and week 12)
- Change in fatigue(Baseline, week 6 and week 12)
- Iron deficiency symptoms(Baseline, week 6 and week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal WomenIron-deficiencyNCT06285799Nemysis Ltd180
已完成
1 期
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy SubjectsSafety IssuesTolerancePulmonary HypertensionIdiopathic Pulmonary FibrosisNCT05427253Vicore Pharma AB80
已完成
1 期
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult ParticipantsMultiple SclerosisNCT06106074Sanofi71
已完成
3 期
Trial of Imatinib for Hospitalized Adults With COVID-19COVID-19NCT04394416University of Maryland, Baltimore21
终止
3 期
Iron in Congestive Heart FailureIron DeficiencyHeart FailureAnemiaNCT01837082University of Ulm18