Iron Deficiency in Celiac Disease: Prevalence, Health Impact, and Clinical Management.
Miguel A Montoro-Huguet, Santos Santolaria-Piedrafita, Pablo Cañamares-Orbis...
https://pubmed.ncbi.nlm.nih.gov/34684433Actively Recruiting
Phase Not Applicable
Age: 6Months - 5Years
All Genders
Healthy Volunteers
ID06742528
Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients With Iron Deficiency Anemia
Led by Arooj Khan · Updated on 2024-12-19
198
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
Sponsors
A
Arooj Khan
Lead Sponsor
K
Khyber Teaching Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of two commonly used iron preparations, Ferrous sulphate and Iron Polymaltose complex, for treating children with iron deficiency anemia. The study focuses on identifying which drug has better efficacy, considering differences in bioavailability, side effects, and cost. Iron deficiency anemia is a widespread condition linked to nutritional and socioeconomic factors and causes low iron levels in the blood. Participants will be randomly assigned to one of two groups. Group A will receive Ferrous sulphate syrup at a dose of 6 mg/kg/day of elemental iron once daily for 8 weeks. Group B will receive Iron Polymaltose complex at the same dose and frequency for 8 weeks. Both treatments are given orally, and the study is designed to compare these two active treatments in a single-masked way. During the 8-week treatment period, researchers will monitor the increase in hemoglobin levels as the primary outcome measure. Participants will be evaluated for treatment response and any side effects. The study includes children with iron deficiency anemia, and participants' progress will be observed through medical history and clinical assessments. The total participation duration aligns with the 8-week treatment period.
CONDITIONS
Brief Title
Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients
Who Can Participate
Age: 6Months - 5Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients having iron deficiency anemia
You will not qualify if you...
- Patients diagnosed as congenital aplastic anemia or thalassemia
- Patients who were transfused in previous 4 weeks
- Children having mal-absorption syndrome and diarrheal illnesses
- Gastrointestinal bleeding suggested by history of hematemesis, melena, or bloody stools
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive either Ferrous sulphate or Iron Polymaltose complex orally once daily for iron deficiency anemia.
Weekly visits for monitoring and assessment
Trial Site Locations
Total: 1 location
1
Khyber Teaching Hospital
Peshawar, KPK, Pakistan, 25000
Actively Recruiting
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Research Team
A
Aimal Khan, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Multifactorial Etiology of Anemia in Celiac Disease and Effect of Gluten-Free Diet: A Comprehensive Review.
Rafael Martín-Masot, Maria Teresa Nestares, Javier Diaz-Castro...
https://pubmed.ncbi.nlm.nih.gov/31652803AGA Technical Review on Gastrointestinal Evaluation of Iron Deficiency Anemia.
Don C Rockey, Osama Altayar, Yngve Falck-Ytter...
https://pubmed.ncbi.nlm.nih.gov/32828801Association of Iron-Deficiency Anemia and Non-Iron-Deficiency Anemia with Neurobehavioral Development in Children Aged 6-24 Months.
Juan Zheng, Jie Liu, Wenhan Yang
https://pubmed.ncbi.nlm.nih.gov/34684422Iron deficiency anemia among children aged 2-5 years in southern Ethiopia: a community-based cross-sectional study.
Alemselam Zebdewos Orsango, Wossene Habtu, Tadesse Lejisa...
https://pubmed.ncbi.nlm.nih.gov/34249504Association of Iron Supplementation Programs with Iron-Deficiency Anemia Outcomes among Children in Brazil.
Carolina Thalya da Silva Paulino, Marislei Nishijima, Flavia Mori Sarti
https://pubmed.ncbi.nlm.nih.gov/33946398