FLIPS: Ferfer Liposomal Iron Performance Study (FLIPS)

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

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: Iron Supplement

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Drug: Iron Supplement; 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.; Other Names: Micro liposomal iron

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd
• Investigators: Study Director: Masood Jawaid, MRCS,FCPS, PharmEvo Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: IDA; iron deficiency anemia; Pakistan; iron supplements; Liposomal iron
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: PE/PK/FLIPS/SP/2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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