Iron Deficiency Anemia, Intravenous Iron Treatment
- 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
• ***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
Patients with Age >18 years who are diagnosed to have iron deficiency anemia, Hb<7g% and admitted in medicine department in JIPMER.
- 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
Name Time Method hemoglobin, iron stores (Ferritin). Baseline,2,4,6th week
- Secondary Outcome Measures
Name Time Method 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, IndiaSUMANTH H SPrincipal investigator8792388531sumanthhs505@gmail.com