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

• Sponsor: Nadirah Rasyid Ridha (Other)
• Overall Status: Completed
• CT.gov ID: NCT06148545
• Collaborator: Hasanuddin University (Other)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency, Anaemia in Children	Drug: Elemental iron; Drug: Elemental iron and Vit D	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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).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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi
• Actual Study Start Date: Mar 30, 2023
• Actual Primary Completion Date: Sep 29, 2023
• Actual Study Completion Date: Sep 29, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitas Hasanuddin	Makassar	Sulawesi Selatan	Indonesia	90245

Sponsors and Collaborators

• Nadirah Rasyid Ridha
• Hasanuddin University

Investigators

• Study Chair: Nadirah R. Ridha, Dr, Hasanuddin University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: Nadirah Rasyid Ridha, Paediatrician, Hasanuddin University
• ClinicalTrials.gov Identifier: NCT06148545
• Other Study ID Numbers: UH23020108
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nadirah Rasyid Ridha, Paediatrician, Hasanuddin University: vitamin D; Iron status; Iron deficiency anemia
• Additional relevant MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Vitamin D; Iron

Study Results

No Results Posted as of Nov 28, 2023