FLIPS: Ferfer Liposomal Iron Performance Study (FLIPS)

• ClinicalTrials.gov Identifier: NCT03112187
• Recruitment Status: Completed
• First Posted: April 13, 2017
• Last Update Posted: January 31, 2019
• Sponsor: PharmEvo Pvt Ltd
• Information provided by (Responsible Party): PharmEvo Pvt Ltd

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Iron Deficiency Anemia	Drug: Iron Supplement	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: FLIPS: Ferfer Liposomal Iron Performance Study
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: January 31, 2019

Arms and Interventions

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 Name: Micro liposomal iron

Outcome Measures

Primary Outcome Measures :

1. Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels [ Time Frame: 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 :

1. Adverse Event [ Time Frame: upto 12 weeks ]

   Number of Participants Who Experienced an Adverse Event

   [ Designated as safety issue: Yes ]

2. Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels [ Time Frame: Week 12 ]
   To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels

Eligibility Criteria

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

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

Contacts and Locations

Locations

Pakistan

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

Lahore, Sindh, Pakistan

Sponsors and Collaborators

PharmEvo Pvt Ltd

Investigators

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

More Information

• Responsible Party: PharmEvo Pvt Ltd
• ClinicalTrials.gov Identifier: NCT03112187
• Other Study ID Numbers: PE/PK/FLIPS/SP/2017-01
• First Posted: April 13, 2017
• Last Update Posted: January 31, 2019
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by PharmEvo Pvt Ltd:

IDA; iron deficiency anemia; iron supplements; Pakistan; Liposomal iron

Additional relevant MeSH terms:

Anemia, Iron-Deficiency; Anemia; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Iron; Trace Elements; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs