MedPath

Iron Deficiency Anemia, Intravenous Iron Treatment

Recruiting
Conditions
Iron deficiency,
Registration Number
CTRI/2022/11/047607
Lead Sponsor
JIPMER
Brief Summary

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|The study will be conducted in JIPMER hospital for 2 years from July 2021 onwards after obtaining IEC approval.  Patients with Age >18 years who are diagnosed to have iron deficiency anemia, Hb<7g% and admitted in medicine department in JIPMER will be included in the study.

Informed consent will be taken from the participants of the study. The process of randomization and allocation shall be explained to the participants.

Patients with Hb <7g/dl, MCV < 80fL, S.Ferritin<30ng/ml will be diagnosed as Iron Deficiency Anemia in the study

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|•      ***Group A -*** Receives Intravenous Ferric Carboxymaltose after test dose , 500-1000mg , diluted in 100ml NS over 15 – 30 min infusion with aseptic precautions and will be monitored for any reactions . Maximum dose 1000mg per day or 15mg/kg

 â€¢      ***Group B  -*** Receives Intravenous Iron sucrose after test dose ,freshly prepared iron sucrose will administered as 200 mg elemental iron in 200mL 0·9% sodium chloride infusion over 3-4 hours with all aseptic precautions and will be monitored for any reactions, and given 300mg Iron Sucrose the next day.



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|**Follow Up**

 Patients will be called , messaged prior to the 2,4,6th week to come to the hospital for follow ups.

 Both Groups will be followed up with

Follow-up after 2,4,6 weeks for Hb level and CBC

Follow up after 4,6 weeks for S.Ferritin, Serum iron studies

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
50
Inclusion Criteria

Patients with Age >18 years who are diagnosed to have iron deficiency anemia, Hb<7g% and admitted in medicine department in JIPMER.

Exclusion Criteria
  • Exclusion Criteria 1.Pregnant female 2.Previous history of allergic reaction to IV iron preparations 3.Patient having Hb ≥ 7g% Hb. 4.Patients having S.
  • Ferritin more than 30ng/ml with an exception to CKD patients.
  • 5.Any active infections,sepsis 6.Ishchemic heart disease 7.Dimorphic anemia 8.Anemic patients with cardiac failure 9.Past history of blood transfusion within past one month 10.Patient with acute GI bleed or any active bleed 11.CKD with Increased ferritin(>500ng/ml) 12.Thalassemia 13.Not willing to give consent.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
hemoglobin, iron stores (Ferritin).Baseline,2,4,6th week
Secondary Outcome Measures
NameTimeMethod
1.To determine the adverse events of both IV preparations.2.To study the degree of variation in RBC indices at the end of 4,6th weeks.

Trial Locations

Locations (1)

JIPMER

🇮🇳

Pondicherry, PONDICHERRY, India

JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
SUMANTH H S
Principal investigator
8792388531
sumanthhs505@gmail.com

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