FLIPS: Ferfer Liposomal Iron Performance Study

Study Overview
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Brief Summary
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To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin and Haematocrit levels

Detailed Description
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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.

Official Title
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FLIPS: Ferfer Liposomal Iron Performance Study

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Iron Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Had a history of iron intolerance Hypersensitivity and allergic of Vit C and Vit B12 Not willing to take informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Drug: Iron Supplement<br>* Ferfer® is a multi-ingredient supplement containing micro-encapsulated iron pyrophosphate (to form liposomes), vitamin C and vitamin B12 which are valuable for the control of nutritional deficiencies or increased organic needs of iron.<br>* Other names: Micro liposomal iron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels | To determine the efficacy of a novel food supplement,Ferfer® to raise the capacity of Haemoglobin levels Designated as safety issue: No | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Number of Participants Who Experienced an Adverse Event [ Designated as safety issue: Yes ] | upto 12 weeks | 
| Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels | To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IDA, iron deficiency anemia, iron supplements, Pakistan, Liposomal iron