A Study to Compare the Gastrointestinal Tolerability of Ferrochel®, Sumalate®,Ferrous Fumarate, Ferrous Sulfate, Ferric Glycinate, and Placebo
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Gastrointestinal questionnaire to measure the gastrointestinal tolerability
研究概览
简要总结
The purpose of this study is to compare the gastrointestinal (GI) tolerability of 5 different iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and ferric glycinate) at the same dose (90mg) and placebo.
详细描述
Anemia, the most common disorder of blood, is characterized by a decrease in number of red blood cells (RBCs) or less than normal quantity of hemoglobin in blood.Hemoglobin is an oxygen-carrying protein inside RBCs that transports oxygen from the respiratory organs to the rest of body. Several vitamins, minerals and nutrients are required for the development and production of RBCs, such as vitamin B12, folic acid and iron. Iron is an essential component of hemoglobin. Iron deficiency accounts for half of the anemia cases worldwide, and iron deficiency anemia is the most common nutritional disorder in the world.Iron deficiency can be the result of inadequate intake in the diet, poor absorption, the extra needs during growth or pregnancy, and blood loss. Thus, children and women are at highest risk.
Full blood count and hemoglobin measurements are used to diagnose anemia, and measurement of serum ferritin level (cutoff of 12-15 mg/l) is considered as the best single and non-invasive test for the diagnosis of iron-deficiency. Treatment of anemia depends on the cause and the severity. Oral iron supplement is the simplest and most cost-effective option to treat anemia and replenish body storage.
The objective of this clinical trial is to compare the gastrointestinal (GI) tolerability of 5 different iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and ferric glycinate) at the same dose (90mg)and placebo. The primary objective is to compare the gastrointestinal tolerability of the above quoted products through:
- Self-assessment questionnaires - Gastrointestinal Symptoms Questionnaire5
- Self reported diaries
The Secondary objective of the study is to assess the change from baseline of the parameters below:
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, 18-50 years of age, inclusive
- •Hemoglobin 8 g/dl - 11 g/dl
- •Ferritin levels < 20 mcg/l (20 ng/mL)
- •Subject, or subject's acceptable representative, has voluntarily signed and dated an informed consent form, approved by a local Ethics Committee/Institutional Review Board prior to any participation in the study
排除标准
- •Pregnant or lactating
- •Severe anemia (hemoglobin 7 g/dl) or other blood abnormality (e.g., leukopenia, thrombocytopenia, polycythemia vera)
- •Serious illness that may confound study results or interfere with compliance
- •Subjects that have followed specific diet, eg. high protein diet, within 30 days prior to study start
- •Subjects that have taken iron supplements within 30 days prior to study start
- •Subjects that are allergic to any of the ingredients in the products
- •Participation in other clinical trials within three months prior to screening
- •Known intolerance to oral iron supplements
- •Habitual smokers (more than 3 cigarettes per week)
- •Other medical conditions that, in the investigator's opinion, may confound study results or prelude the subject's ability to safely complete the trial
结局指标
主要结局
Gastrointestinal questionnaire to measure the gastrointestinal tolerability
时间窗: change from baseline in Gastrointestinal questionnaire on 7 days after the last dose of 30 days investigational product consumption
The gastrointestinal tolerability of the products will be assessed by self-assessment questionnaires and self-reported diaries at baseline (screening), day 0, day 15, day 30 of investigational product consumption, and 7 days after finished the investigational product.
次要结局
- the laboratory result to measure the change from baseline(up to 30 days of investigational product consumption)