FLIPS: Ferfer Liposomal Iron Performance Study

NCT03112187 | Completed Phase 4

• 1 other identifier: PE/PK/FLIPS/SP/2017-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Deficiency Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse Event

  upto 12 weeks

• Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels

  Week 12

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Iron Supplement DRUG

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.

Also known as: Micro liposomal iron

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Had a history of iron intolerance
• Hypersensitivity and allergic of Vit C and Vit B12
• Not willing to take informed consent

Sponsors & Collaborators

• PharmEvo Pvt Ltd: lead

Study Sites (1)

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

Lahore, Sindh, Pakistan

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Masood Jawaid, MRCS,FCPS

  PharmEvo Pvt Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 13, 2017
• Study Start: August 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: January 31, 2019
• Last Updated: January 31, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)