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NCT Number: NCT06148545

Effect of Iron and Vitamin D Supplementation to Iron Status in Iron Deficiency Anemia

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.

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Key information

Conditions

Iron Deficiency, Anaemia in Children Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Hasanuddin

Makassar, South Sulawesi, 90245, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Children's Iron deficiency anemia
  • Must be able to drink syrups

Exclusion criteria

  • Patients who have diarrhea
  • Patients who experience vomiting
  • Severe anemia
  • Post Transfusion

Treatment and study plan

Elemental Iron

Drug

Group A who received standard therapy (Fe preparations) 3 mg/kg BW/day

Other names: Iron supplementation

Elemental iron and Vit D

Drug

Group B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU).

Other names: Iron supplementation with Vitamin D

Primary outcomes

  1. This study was to compare the effect of standard therapy with standard therapy plus vitamin D in children with IDA.

    Time frame: After 4 weeks

    • Comparing pre-treatment routine blood test, serum iron, and serum ferritin levels between iron supplementation and iron and vitamin D supplementation groups.
    • Comparing the levels of routine blood tests, serum iron, and serum ferritin results after treatment between iron supplementation and iron and vitamin D supplementation groups.

Secondary outcomes

  1. Comparison of mean changes in complete blood count, serum iron, and serum ferritin level

    Time frame: after 4 weeks

    • Comparing the difference in routine blood test results, and ferritin before and after treatment between the iron supplementation group and the iron and vitamin D supplementation group.
    • Comparing the difference of routine blood test results, and serum iron ferritin before and after therapy in the iron supplementation group.
    • Comparing the difference of routine blood test results, serum iron ferritin before and after therapy in iron supplementation and Vitamin D supplementation groups.

Sponsors and collaborators

Lead sponsor

Nadirah Rasyid Ridha

Other

Collaborators

  • Hasanuddin University

Registry information

Official study title

Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 28, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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