Assessment of the Efficacy of a Low-Dose Iron Supplement in Restoring Iron Levels to Normal Range Without Promoting Constipation or Adverse Gastrointestinal Effects Among Healthy Premenopausal Women With Iron Deficiency Without Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- High Sensitivity C-Reactive Protein (hs-CRP)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency. The primary outcomes will be an Iron Panel of Serum Iron, Ferritin, Total iron-binding capacity, Transferrin saturation, Complete Blood Count, and high sensitivity - C-Reactive Protein. Secondary outcomes will be surveys on gastrointestinal distress/discomfort and well-being. Adverse events will also be reported.
详细描述
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency.
A total of 82 premenopausal female subjects over the age of 18 years old are planned for this study. Enrolled subjects will be assigned a unique study number in the 100 series as the subject ID for the study to maintain anonymity. The subject ID will be assigned in sequential order starting with 101 (i.e., 101, 102, 103, etc). After signing the informed consent document, enrolled subjects will be screened, and qualifying subjects will be randomly assigned to one of two groups (Group A or Group B) depending on the treatment (liquid iron supplement or placebo). Following random assignment, subjects will revisit the laboratory to complete baseline testing for primary, secondary, and exploratory outcomes. After 4 weeks of daily supplementation of their respective randomly assigned condition, subjects return to the laboratory for reassessment of secondary outcomes. The last laboratory visit will occur following 8 weeks of daily supplementation in which subjects will be reassessed on all outcomes in a manner identical to baseline.
GROUPS:
- Group A: Single-dose containing 10 mL of a liquid iron formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.
- Group B: Single-dose containing 10 mL of the placebo formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.
VISITS:
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects > 18 years old
- •Premenopausal (experiencing regular menstrual cycles)
- •Hemoglobin > 11g/dL
- •Serum ferritin < 70 ng/mL
- •hs-CRP < 3 mg/L
- •BMI 18 - 29.9 kg/m2
- •No intake of dietary supplements containing iron 30 days prior to enrollment
- •Willing and able to give written informed consent
- •Able to read, understand, sign and date the informed consent document (English only)
- •Able and willing to comply with the schedule visit(s) and study requirements.
排除标准
- •Currently taking (within the past 14 days) dietary supplements including, vitamins (any), minerals, protein shakes, vitamin water, other supplements
- •History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
- •History or current malignancy
- •Receiving chemotherapy agents or radiation treatments
- •Prior health issues showing high CRP or other inflammatory markers
- •Pregnancy or has breast fed within 3 months prior to enrollment
- •BMI <18 or >25 kg/m2
- •Diagnosis of a terminal illness
- •Use of prescription medications that impact digestion (i.e., proton pump inhibitor medications, other)
- •History of alcohol abuse
- •History or current drug abuse
- •History or current cigarette smoke (including vaping) within the past 14 days from the screening visit
- •Insulin-dependent diabetes and/or metformin use
- •Chronic kidney or liver disease
- •Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such condition might be aggravated as a result of treatment
- •The investigator feels that for any reason the subject is not eligible to participate in the study
- •Use within 24 hours preceding enrollment of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia)
- •History of uncontrolled cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- •History, or current bleeding disorders (i.e., hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants
- •Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
- •A family member of the investigator or an employee of the investigator
- •Participation in any other investigational study within 30 days prior to consent
结局指标
主要结局
High Sensitivity C-Reactive Protein (hs-CRP)
时间窗: Week 0 and Week 8
Changes in hs-CRP in fasted serum blood samples.
Serum Iron
时间窗: Week 0 and Week 8
Changes in Iron in fasted serum blood samples.
Serum Ferritin
时间窗: Week 0 and Week 8
Changes in Ferritin in fasted serum blood samples.
Total Iron-Binding Capacity (TIBC)
时间窗: Week 0 and Week 8
Changes in TIBC in fasted serum blood samples.
Transferrin Saturation (tSAT)
时间窗: Week 0 and Week 8
Changes in tSAT in fasted serum blood samples.
Complete Blood Count (CBC)
时间窗: Week 0 and Week 8
Changes in complete blood count with differential will be assessed via fasted serum blood samples
次要结局
- Functional Bowel Index(Week 0, Week 4, and week 8)
- Gastrointestinal symptom rating scale(Week 0, Week 4, and week 8)
- Adverse Events(Week 0, Week 4, and Week 8)
- Patient Assessment of Constipation - Symptoms Questionnaire(Week 0, Week 4, and week 8)
- Abbreviated Profile of Mood States(Week 0 and Week 8)