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Completed

NCT Number: NCT03112187

FLIPS: Ferfer Liposomal Iron Performance Study

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

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Lahore, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Micro liposomal iron

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

PharmEvo Pvt Ltd

Industry

Registry information

Acronym: FLIPS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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