Clinical trial
Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi
Name
UH23020108
Description
Iron and vitamin D are two essential micronutrients for the normal growth of young children, and their deficiencies are still a major health problem in developing countries, including Indonesia. A significant association between vitamin D deficiency and anemia has been reported throughout the world. Several studies in various populations all over the world suggest a high degree of association between Iron deficiency anemia and vitamin D deficiency. It is still controversial which deficiency causes the other but this association should be addressed in view of a better treatment proposal. The aim of the present study was to determine the effect of vitamin D supplementation on iron status in iron deficiency anemia.
Trial arms
Trial start
2023-03-30
Estimated PCD
2023-09-29
Trial end
2023-09-29
Status
Completed
Treatment
Elemental iron
Group A who received standard therapy (Fe preparations) 3 mg/kg BW/day
Arms:
Iron supplementation
Other names:
Iron supplementation
Elemental iron and Vit D
Group B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU).
Arms:
Iron and Vitamin D supplementation
Other names:
Iron supplementation with Vitamin D
Size
57
Primary endpoint
This study was to compare the effect of standard therapy with standard therapy plus vitamin D in children with IDA.
After 4 weeks
Eligibility criteria
Inclusion Criteria:
1. Clinical diagnosis of Children's Iron deficiency anemia
2. Must be able to drink syrups
Exclusion Criteria:
1. Patients who have diarrhea
2. Patients who experience vomiting
3. Severe anemia
4. Post Transfusion
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'children with a diagnosis of iron deficiency anemia age 1-5 years. Patients were divided into two groups, namely group A which received standard therapy (Fe preparations) 3 mg/kgBW/day, and group B (which received standard therapy combination vitamin D, 400IU).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 57, 'type': 'ACTUAL'}}
Updated at
2023-11-28
1 organization
2 products
2 indications
Organization
Nadirah Rasyid RidhaProduct
Elemental ironIndication
Iron DeficiencyIndication
Anemia in ChildrenProduct
Elemental Iron + Vitamin D