Iron Deficiency Anemia
Conditions
Keywords
IDA, iron deficiency anemia, iron supplements, Pakistan, Liposomal iron
Brief summary
To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin and Haematocrit levels
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.
Interventions
DRUGIron 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.
Sponsors
PharmEvo Pvt Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | upto 12 weeks | Number of Participants Who Experienced an Adverse Event \[ Designated as safety issue: Yes \] |
| Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels | Week 12 | To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels |
Countries
Pakistan
Outcome results
None listed