Effect of Iron and Vitamin D Supplementation to Iron Status in Iron Deficiency Anemia
NCT ID: NCT06148545
Last Updated: 2023-11-28
Study Results
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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COMPLETED
NA
57 participants
INTERVENTIONAL
2023-03-30
2023-09-29
Brief Summary
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Detailed Description
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The inclusion criteria in this study were children aged 1-5 years, diagnosed with iron deficiency anemia, and parents/caregivers willing to include their children in this study. Children who had received iron preparation, and previous blood transfusion were excluded in this study. Patients who refused blood tests after giving therapy for 4 weeks were declared dropouts.
Researchers will provide informed consent to parents/caregivers of children who met the research criteria. Anamnesis, general physical examination, and complete blood count (CBC) analysis were carried out: hemoglobin (Hb), Red Blood cell (RBC), Mean erythrocyte volume (MCV), Mean erythrocyte hemoglobin (MCH), Reticulocytes, serum iron, and serum ferritin. Iron deficiency anemia if the level of hemoglobin \<11 g/dL, microcytic Hypochromia, serum ferritin \< 30 pg/dl, then given iron and vitamin D preparation for 4 weeks, then checked again complete blood count, serum fe and serum ferritin. The research results are recorded in a research form and the data is grouped and SPSS version 21.0 software is used for data analysis. A P value \<0.05 was considered for statistical analysis. This study was approved by the ethics and research committee of the faculty of medicine, at Hasanuddin University
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Iron supplementation
Children with a diagnosis of iron deficiency anemia. Patients who received standard therapy (Fe preparations) 3 mg/kg BW/day for 4 weeks, were then checked again for complete blood count, serum fe, and serum ferritin.
Elemental iron
Group A who received standard therapy (Fe preparations) 3 mg/kg BW/day
Iron and Vitamin D supplementation
Children with a diagnosis of iron deficiency anemia. Patients who received standard therapy (Fe preparations) 3 mg/kgBW/day and received standard therapy combination vitamin D, 400 IU for 4 weeks, were then checked again for complete blood count, serum fe, and serum ferritin.
Elemental iron and Vit D
Group B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU).
Interventions
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Elemental iron
Group A who received standard therapy (Fe preparations) 3 mg/kg BW/day
Elemental iron and Vit D
Group B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must be able to drink syrups
Exclusion Criteria
2. Patients who experience vomiting
3. Severe anemia
4. Post Transfusion
1 Year
5 Years
ALL
Yes
Sponsors
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Hasanuddin University
OTHER
Nadirah Rasyid Ridha
OTHER
Responsible Party
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Nadirah Rasyid Ridha
Paediatrician
Principal Investigators
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Nadirah R. Ridha, Dr
Role: STUDY_CHAIR
Hasanuddin University
Locations
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Universitas Hasanuddin
Makassar, South Sulawesi, Indonesia
Countries
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References
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Samson KLI, Fischer JAJ, Roche ML. Iron Status, Anemia, and Iron Interventions and Their Associations with Cognitive and Academic Performance in Adolescents: A Systematic Review. Nutrients. 2022 Jan 5;14(1):224. doi: 10.3390/nu14010224.
Related Links
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The effect of vitamin D supplementation on hemoglobin concentration: a systematic review and meta-analysis
The effect of iron on vitamin D level in children with combined iron and vitamin D deficiency
Other Identifiers
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UH23020108
Identifier Type: -
Identifier Source: org_study_id