Evaluation of efficacy of Heme Iron Polypeptide in comparison to Ferrous sulphate in children with Iron Deficiency Anemia- Randomised Control Trial
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Increase in hemoglobin with heme Iron polypeptide in comparison to Ferrous sulphate in children in Iron Deficiency Anemia
Study Overview
Brief Summary
Iron Deficiency Anemia - IDA affects around 67 percent of Indian children, making it a major public health problem. Oral iron supplementation is the mainstay of treatment, but ferrous salts often cause gastrointestinal side effects. Heme Iron Polypeptide- HIP shows superior bioavailability and better tolerance compared to ferrous sulphate. Evidence suggests HIP may improve hemoglobin more effectively, but comparative studies in children are limited.
This study is an open-labeled randomized controlled trial conducted at KAHER JNMC, Belagavi, comparing efficacy of heme Iron polypeptide versus Ferrous sulphate in children with Iron Deficiency Anemia. A total of 84 children aged 1 to 18 years with IDA will be randomized into two groups. Group 1 will receive HIP, while Group 2 will receive ferrous sulphate, both as daily oral therapy. Blood investigations and detailed physical examination will be done, and the children will be followed up telephonically.
Primary outcome is hemoglobin rise after 84 days of treatment
Secondary outcomes are hepcidin levels association and GI side effects. Data will be analyzed using appropriate statistical methods, with significance at p less than 0.05. The study aims to determine whether HIP is a more effective and safer alternative to ferrous sulphate in treating pediatric IDA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All children between 1 year to 18 years with Iron Deficiency Anemia.
Exclusion Criteria
- •Patients who have received blood transfusion in the last three months
- •Patients who received iv Iron in the last one month
- •Patients who have malabsorption syndrome and inflammatory bowel disease
- •Patients who suffer from chronic blood loss like portal hypertension, anastomosis leak from surgical site, hemorrhoids, polyp, etc
- •Patients not consenting for study.
Outcomes
Primary Outcomes
Increase in hemoglobin with heme Iron polypeptide in comparison to Ferrous sulphate in children in Iron Deficiency Anemia
Time Frame: After 84 days of intervention
Secondary Outcomes
- Relation between heme Iron polypeptide & Ferrous sulphate on hepcidin levels(After 24 hours of initiating intervention)
- Gastro intestinal side effects in both groups of heme Iron polypeptide & Ferrous sulphate(Every week after starting intervention till 84 days)
Investigators
Dr Arshiya Shaikh
KAHER Jawaharlal Nehru Medical College Belgaum