FLIPS: Ferfer Liposomal Iron Performance Study

Phase 4

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Iron Supplement

• Registration Number: NCT03112187
• Lead Sponsor: PharmEvo Pvt Ltd

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Study Start: 2017-08-01
• Primary Completion: 2018-11-30
• Status Verified: 2018-12
• Last Update Submitted: 2019-01-30
• Study Completion: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Iron Supplement	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

Primary Outcome Measures

Name	Time	Method
Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels	Week 12	To determine the efficacy of a novel food supplement,Ferfer® to raise the capacity of Haemoglobin levels; Designated as safety issue: No

Secondary Outcome Measures

Name	Time	Method
Adverse Event	upto 12 weeks	Number of Participants Who Experienced an Adverse Event; \[ Designated as safety issue: Yes \]
Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels	Week 12	To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels

Trial Locations

Locations (1)

Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala; 🇵🇰 Lahore, Sindh, Pakistan