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

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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency, Anaemia in Children
• Intervention / Treatment: Drug: Elemental iron; Drug: Elemental iron and Vit D

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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Sulawesi Selatan
    • Makassar, Sulawesi Selatan, Indonesia, 90245
      • Universitas Hasanuddin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Elemental iron; Group A who received standard therapy (Fe preparations) 3 mg/kg BW/day; Other Names: Iron supplementation
Experimental: 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.	Drug: Elemental iron and Vit D; Group B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU).; Other Names: Iron supplementation with Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
This study was to compare the effect of standard therapy with standard therapy plus vitamin D in children with IDA.	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.	After 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of mean changes in complete blood count, serum iron, and serum ferritin level	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.	after 4 weeks

Collaborators and Investigators

• Sponsor: Nadirah Rasyid Ridha
• Collaborators: Hasanuddin University
• Investigators: Study Chair: Nadirah R. Ridha, Dr, Hasanuddin University

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Iron deficiency anemia; vitamin D; Iron status
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Iron
• Other Study ID Numbers: UH23020108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No