NCT05990166已完成2 期
Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Serum ferritin (SF) concentrations between active intervention and placebo groups at endline (six months). Proportion of participants remaining iron deficient between active intervention and placebo groups at six months.
研究概览
简要总结
The goal of this clinical trial is to determine if taking a mineral-enriched powder can raise blood iron levels compared to a placebo powder in reproductive-aged women with iron deficiency. The main questions it aims to answer are:
- Does the mineral-enriched powder raise blood iron levels compared to a placebo powder in women when it is taken every day for six months?
- How many participants still have iron deficiency after six months of taking the mineral-enriched powder compared to a placebo powder?
Participants in this clinical trial will drink the mineral-enriched powder containing ferrous iron and zinc sulphate monohydrate or a placebo powder mixed with 1 litre of water daily for six months. The placebo is a look-alike substance that does not contain active ingredients (iron and zinc). Participants will also have to:
- Complete an online "study diary" every two weeks for six months
- Provide a blood sample once a month for six months
- Attend three in-person visits with a researcher, at enrolment (baseline), midline (three months), and endline (six months)
- Complete three sets of online questionnaires (following each in-person visit)
- Complete three sets of dietary assessments (following each in-person visit)
- Provide three stool samples (following each in-person visit)
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)
盲法说明
All participants, researchers, and the study physician will be blinded to the treatment group (active intervention or placebo) to which participants have been randomised. A delegated unblinded staff member will be permitted to unblind participants for safety purposes, if requested by the principal investigators or the study physician.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* Non-pregnant and non-lactating
- •* English speaking with the ability to give informed consent
- •* 18-35 years of age (inclusive)
- •* Women who are biologically female
- •* Iron deficient (SF \>/=12μg/L and \/=110 g/L
- •* Willing and able to agree to the requirements and lifestyle restrictions of this study
- •* Able to understand and read the questionnaires in English and carry out all study-related procedures
- •* Located in the greater Ottawa area and a resident of Ontario
排除标准
- •Individuals who are lactating, pregnant, or planning to become pregnant during the study
- •Individuals who are not maintaining adequate birth control measures
- •Adequate birth control measures include any option that will adequately prevent pregnancy including: contraceptives, lifestyle choices, complete abstinence, or as a result of other medical methods, procedures, or conditions
- •Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients
- •Are using vitamin and mineral supplements containing iron and/or zinc
- •SF concentrations <12 μg/L or >30 μg/L
- •Having moderate or severe anaemia (Hb <109 g/L)
- •Expecting to change diet and exercise regimen in the next 6 months
- •Are frequent blood donors
- •Have donated blood in the last four months
- •Donate blood more than two to three times per year
- •Had major surgery in the past three months
- •Have planned surgery during the course of the study
- •History of problematic alcohol or substance use in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program)
- •Use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration
- •Using any of the following drugs:
- •Antacids or proton pump inhibitors, H2 blockers
- •Salicylates, aspirin, corticosteroids, nonsteroidal anti-inflammatory drugs
- •Anticoagulants, antiplatelet compounds
- •Drugs with known contraindication with iron supplementation or fortification
- •Antiviral medications
- •Levothyroxine (Synthroid)
- •Known medical history of specific conditions including:
- •Gastrointestinal disorders: celiac disease, ulcerative colitis, and Crohn's disease
- •Gastric cancer and gastric polyps
- •Colon cancer
- •Diverticular bleeding
- •Inflammatory bowel diseases
- •Angiodysplasia
- •Helicobacter pylori infection
- •Hookworm (Ancylostoma duodenale and Necator americanus)
- •Defects of hemostasis (hereditary hemorrhagic telangectasia, von Willebrand disease)
- •Gastrectomy, duodenal bypass, bariatric surgery
- •Erythropoiesis-stimulating agent therapy
- •Chronic kidney disease
- •Hemochromatosis
- •Hemoglobinopathies
- •Blood clotting disorder
- •Have any other active or unstable medical conditions or use of medications/supplements/ therapies that according to the scientific literature, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant or the quality of the study data.
研究组 & 干预措施
Active intervention
Experimental
Mineral-enriched powder
干预措施: Mineral-enriched powder (Other)
Placebo
Placebo Comparator
Placebo powder
干预措施: Placebo powder (Other)
结局指标
主要结局
Serum ferritin (SF) concentrations between active intervention and placebo groups at endline (six months). Proportion of participants remaining iron deficient between active intervention and placebo groups at six months.
时间窗: Six months
SF concentrations will be measured using standard clinical lab assay.
次要结局
- Change in SF concentrations from enrolment (baseline), to midline (three months), and endline (six months).(Baseline, three months, six months)
- Levels of metabolites (circulating metabolome) at baseline, three months, and six months.(Baseline, three months, six months)
- Dietary recall: Healthy Eating Index (HEI) at baseline, three months, and six months.(Baseline, three months, six months)
- Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months).(Baseline, three months, six months)
- Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months.(Baseline, three months, six months)
- Dietary recall: proportion of participants meeting dietary reference intakes at baseline, three months, and six months.(Baseline, three months, six months)
- Dietary recall: dietary patterns at baseline, three months, and six months.(Baseline, three months, six months)
- Dietary recall: Dietary Inflammatory Index (DII) at baseline, three months, and six months.(Baseline, three months, six months)
- Self-reported perceptions of health at baseline and six months.(Baseline, six months)
- Feasibility: Adherence to the consumption regimen for the regular use of the powder.(Bi-weekly through study completion, approximately 7 months)
- Feasibility: Adherence to the consumption regimen for the regular use of the powder at three months and six months.(Baseline, three months, six months)
- Feasibility: Self-reported barriers to use of the powder.(Six months)
- Palatability.(Six months)
- Economic: Overall health status.(Six months)
- Economic: Health state/health state index.(Six months)
- Economic: Quality adjusted life years (QALYs).(Six months)
- Safety (adverse events/harms).(Baseline, three months, six months, and seven months)
研究者
Kristin Connor, PhD
Associate Professor
Carleton University
研究点 (2)
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