Clinical trial NCT06148545: Effect of Iron and Vitamin D Supplementation to Iron Status in Iron Deficiency Anemia
Official title: Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency, Anaemia in Children
Keywords: vitamin D
Iron status
Iron deficiency anemia
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
Collaborators: name: Hasanuddin University
First posted: 2023-11-28
Enrollment: 57
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This research is a randomized controlled trial study conducted in Makassar, South of Sulawesi, Indonesia from April to October 2023. This study was conducted on children with a diagnosis of iron deficiency anemia. 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).

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

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

Primary outcomes:
measure: This study was to compare the effect of standard therapy with standard therapy plus vitamin D in children with IDA.
timeFrame: After 4 weeks
Secondary outcomes:
measure: Comparison of mean changes in complete blood count, serum iron, and serum ferritin level
timeFrame: after 4 weeks
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Universitas Hasanuddin
state: Sulawesi Selatan
Study officials:
affiliation: Hasanuddin University
name: Nadirah R. Ridha, Dr
role: STUDY_CHAIR
References:
citation: 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.