Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients

NCT06742528 | Recruiting

• 1 other identifier: 591/DME/KMC
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.

Conditions

Iron Deficiency Anemia; Iron Deficiency, Anaemia in Children

Keywords

IRON POLMALTOSE COMPLEX; FERROUS SULPHATE; Iron Deficiency, Anaemia in Children

Outcome Measures

Primary Outcomes (1)

• Increase Of Hemoglobin Level

  Increase in Hemoglobin level measured by a Complete Blood Count as compared to pre treatment Hemoglobin

  8 weeks

Study Arms (2)

Group A (Ferrous sulphate)

ACTIVE COMPARATOR

Group A will be given Ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form.

Drug: Ferrous sulfate

Group B (Iron Polymaltose complex)

ACTIVE COMPARATOR

Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.

Drug: Iron Polymaltose Complex

Interventions

Ferrous sulfate DRUG

ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form.

Group A (Ferrous sulphate)

Iron Polymaltose Complex DRUG

Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.

Group B (Iron Polymaltose complex)

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients having iron deficiency anemia

You may not qualify if:

• Patients diagnosed as congenital aplastic anemia or thalassemia (Determined from medical record).
• Patients who were transfused in previous 4 weeks (will be determined on history)
• Children having mal-absorption syndrome and diarrheal illnesses. (will be determined on history and medical record)
• Gastrointestinal bleeding suggested by history of hematemesis (bloody vomit), melena (black colored stools) or bloody stools.

Sponsors & Collaborators

• Arooj Khan: lead
• Khyber Teaching Hospital: collaborator

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

Related Publications (6)

• Montoro-Huguet MA, Santolaria-Piedrafita S, Canamares-Orbis P, Garcia-Erce JA. Iron Deficiency in Celiac Disease: Prevalence, Health Impact, and Clinical Management. Nutrients. 2021 Sep 28;13(10):3437. doi: 10.3390/nu13103437.

  PMID: 34684433 BACKGROUND

• Martin-Masot R, Nestares MT, Diaz-Castro J, Lopez-Aliaga I, Alferez MJM, Moreno-Fernandez J, Maldonado J. Multifactorial Etiology of Anemia in Celiac Disease and Effect of Gluten-Free Diet: A Comprehensive Review. Nutrients. 2019 Oct 23;11(11):2557. doi: 10.3390/nu11112557.

  PMID: 31652803 BACKGROUND

• Rockey DC, Altayar O, Falck-Ytter Y, Kalmaz D. AGA Technical Review on Gastrointestinal Evaluation of Iron Deficiency Anemia. Gastroenterology. 2020 Sep;159(3):1097-1119. doi: 10.1053/j.gastro.2020.06.045. Epub 2020 Aug 21. No abstract available.

  PMID: 32828801 BACKGROUND

• Zheng J, Liu J, Yang W. Association of Iron-Deficiency Anemia and Non-Iron-Deficiency Anemia with Neurobehavioral Development in Children Aged 6-24 Months. Nutrients. 2021 Sep 28;13(10):3423. doi: 10.3390/nu13103423.

  PMID: 34684422 BACKGROUND

• Orsango AZ, Habtu W, Lejisa T, Loha E, Lindtjorn B, Engebretsen IMS. Iron deficiency anemia among children aged 2-5 years in southern Ethiopia: a community-based cross-sectional study. PeerJ. 2021 Jun 28;9:e11649. doi: 10.7717/peerj.11649. eCollection 2021.

  PMID: 34249504 BACKGROUND

• Paulino CTDS, Nishijima M, Sarti FM. Association of Iron Supplementation Programs with Iron-Deficiency Anemia Outcomes among Children in Brazil. Nutrients. 2021 Apr 30;13(5):1524. doi: 10.3390/nu13051524.

  PMID: 33946398 RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferrous sulfate; teferrol

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Aimal Khan, MBBS

CONTACT

03481903336; aimalkhan871207@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be divided randomly in two groups using blocked randomization generated by computer software.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Resident, Department of Child Health

Model Details: Brief history and demographic data including age, gender, duration of pallor, residence, weight, educational level of mother, socioeconomic status of father will be noted. Under aseptic techniques 5cc venous sample will be drawn and send to hospital laboratory for baseline hemoglobin and serum ferritin level. All patients will be dewormed before starting therapy by giving oral albendazole l0 ml stat dose. Patients will be divided randomly in two groups using blocked randomization generated by computer software. Group A will be given ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form. Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks. Both the groups will be called for follow up. Hemoglobin level will be assessed after 8 week of therapy.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 19, 2024
• Study Start: January 10, 2024
• Primary Completion: December 25, 2024
• Study Completion: January 10, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)