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FLIPS: Ferfer Liposomal Iron Performance Study (FLIPS)

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Iron Supplement
Sponsored by
PharmEvo Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring IDA, iron deficiency anemia, iron supplements, Pakistan, Liposomal iron

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Event
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
To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels

Full Information

First Posted
March 27, 2017
Last Updated
January 30, 2019
Sponsor
PharmEvo Pvt Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03112187
Brief Title
FLIPS: Ferfer Liposomal Iron Performance Study
Acronym
FLIPS
Official Title
FLIPS: Ferfer Liposomal Iron Performance Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmEvo Pvt Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
IDA, iron deficiency anemia, iron supplements, Pakistan, Liposomal iron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Iron Supplement
Other Intervention Name(s)
Micro liposomal iron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels
Description
To determine the efficacy of a novel food supplement,Ferfer® to raise the capacity of Haemoglobin levels Designated as safety issue: No
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Adverse Event
Description
Number of Participants Who Experienced an Adverse Event [ Designated as safety issue: Yes ]
Time Frame
upto 12 weeks
Title
Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels
Description
To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels
Time Frame
Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masood Jawaid, MRCS,FCPS
Organizational Affiliation
PharmEvo Pvt Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala
City
Lahore
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

FLIPS: Ferfer Liposomal Iron Performance Study

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