FLIPS: Ferfer Liposomal Iron Performance Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels
研究概览
简要总结
To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin and Haematocrit levels
详细描述
Anemia, described as a low blood Haemoglobin concentration, has been shown to be a public health problem that impacts low-, center- and high-earnings nations and has great unfavorable health results, as well as unfavorable influences on social and monetary development . even though the most dependable indicator of anemia on the populace stage is blood Haemoglobin attention, measurements of this attention by myself do now not determine the cause of anemia. Anemia may additionally result from a number of causes, with the maximum great contributor being iron deficiency. approximately 30%- 50% of instances of anemia are taken into consideration to be because of iron deficiency.
Doctor will evaluate on the basis of inclusion or exclusion criteria, lab values and overall assessment and then enroll in this clinical trial. During the study patient will visit the Doctor four times, Day 0 week 4, week 8 and week 12. Doctor will investigate the Hemoglobin level and Hematocrit level and also evaluate the adverse effects and tolerability of Ferfer® at week 2 and week 8. Doctor also instructed to take the food supplements, twice daily, once in a morning and once in evening independently by food intake as Ferfer® has no interaction with food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Iron deficiency anemia (Hemoglobin <8 to >5 g/dl)
- •Subjects able to provide written informed consent;
- •Subjects already treated with other iron supplements or drugs that experienced side effects (not including allergy) related to iron administration.
- •Wash out period will be a week
排除标准
- •Had a history of iron intolerance
- •Hypersensitivity and allergic of Vit C and Vit B12
- •Not willing to take informed consent
研究组 & 干预措施
Intervention
Ferfer is a food supplement in liposomal form, with essential, vitamins including Vitamin C and Vitamin B12. Ferfer directly dissolves in the mouth without the need for water. The technology of liposomal microencapsulation, allows daily iron supplementation without any of the typical side effects of conventional oral iron supplements, such as heartburn, diarrhea, constipation, nausea and coloring of the mucous membranes and of the stools, which increases patient compliance. It has no metallic taste or smell, does not color mucous membrane and has excellent tolerability
干预措施: Iron Supplement (Drug)
结局指标
主要结局
Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels
时间窗: Week 12
To determine the efficacy of a novel food supplement,Ferfer® to raise the capacity of Haemoglobin levels Designated as safety issue: No
次要结局
- Adverse Event(upto 12 weeks)
- Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels(Week 12)