Clinical trial NCT06742528: Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients
Official title: Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients With Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Iron Deficiency Anemia
Iron Deficiency, Anaemia in Children
Keywords: IRON POLMALTOSE COMPLEX
FERROUS SULPHATE
Iron Deficiency, Anaemia in Children
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Khyber Teaching Hospital
First posted: 2024-12-19
Enrollment: 198
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Anemia remains a condition with high prevalence in populations worldwide. It is predominantly associated with nutritional status and socioeconomic conditions or hereditary diseases. The majority of anemia cases are linked to iron deficiency-named iron-deficiency anemia resulting from low intake of iron-rich foods in the diet, or from substantial blood loss.

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.

Eligibility criteria: Inclusion Criteria:

* Patients having iron deficiency anemia

Exclusion Criteria:

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

Primary outcomes:
measure: Increase Of Hemoglobin Level
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: KPK
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.