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

NCT ID: NCT06742528

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-01-10

Brief Summary

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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

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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.

Conditions

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Iron Deficiency Anemia Iron Deficiency, Anaemia in Children

Keywords

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IRON POLMALTOSE COMPLEX FERROUS SULPHATE Iron Deficiency, Anaemia in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be divided randomly in two groups using blocked randomization generated by computer software.

Study Groups

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Group A (Ferrous sulphate)

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 Type ACTIVE_COMPARATOR

Ferrous sulfate

Intervention Type DRUG

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

Group B (Iron Polymaltose complex)

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

Group Type ACTIVE_COMPARATOR

Iron Polymaltose Complex

Intervention Type DRUG

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

Interventions

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Ferrous sulfate

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

Intervention Type DRUG

Iron Polymaltose Complex

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khyber Teaching Hospital

OTHER

Sponsor Role collaborator

Arooj Khan

OTHER

Sponsor Role lead

Responsible Party

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Arooj Khan

Post Graduate Resident, Department of Child Health

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Khyber Teaching Hospital

Peshawar, KPK, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Aimal Khan, MBBS

Role: CONTACT

Phone: 03481903336

Email: [email protected]

Facility Contacts

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Arooj Khan, MBBS

Role: primary

Aimal Khan, MBBS

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 34684433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31652803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32828801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34684422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34249504 (View on PubMed)

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.

Reference Type RESULT
PMID: 33946398 (View on PubMed)

Other Identifiers

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591/DME/KMC

Identifier Type: -

Identifier Source: org_study_id