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FLIPS: Ferfer Liposomal Iron Performance Study (FLIPS)

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ClinicalTrials.gov Identifier: NCT03112187
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
PharmEvo Pvt Ltd

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112187


Contacts
Contact: Lubna Shahzad, MBBS 9221-34315195 masood.jawaid@pharmevo.biz
Contact: Masood Jawaid, MRCS,FCPS 9221-34315195 masood.jawaid@pharmevo.biz

Locations
Pakistan
Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala Recruiting
Lahore, Sindh, Pakistan
Contact: Lubna Shahzad, MBBS         
Sponsors and Collaborators
PharmEvo Pvt Ltd
Investigators
Study Director: Masood Jawaid, MRCS,FCPS PharmEvo Pvt Ltd

Responsible Party: PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier: NCT03112187     History of Changes
Other Study ID Numbers: PE/PK/FLIPS/SP/2017-01
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: April 2017
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, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs