FLIPS: Ferfer Liposomal Iron Performance Study

Iron Deficiency Anemia Clinical Trial

— FLIPS  

Official title:

FLIPS: Ferfer Liposomal Iron Performance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112187
• Other study ID #: PE/PK/FLIPS/SP/2017-01
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: December 2018
• Source: PharmEvo Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala	Lahore	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
PharmEvo Pvt Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Event	Number of Participants Who Experienced an Adverse Event; [ Designated as safety issue: Yes ]	upto 12 weeks
Secondary	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