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

NCT06148545 | Completed

• 1 other identifier: UH23020108
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency, Anaemia in Children

Keywords

vitamin D; Iron status; Iron deficiency anemia

Outcome Measures

Primary Outcomes (1)

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

  1. Comparing pre-treatment routine blood test, serum iron, and serum ferritin levels between iron supplementation and iron and vitamin D supplementation groups. 2. 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 Outcomes (1)

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

  after 4 weeks

Study Arms (2)

Iron supplementation

EXPERIMENTAL

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

Iron and Vitamin D supplementation

EXPERIMENTAL

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

Interventions

Elemental iron DRUG

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

Also known as: Iron supplementation

Iron supplementation

Elemental iron and Vit D DRUG

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

Also known as: Iron supplementation with Vitamin D

Iron and Vitamin D supplementation

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nadirah Rasyid Ridha: lead
• Hasanuddin University: collaborator

Study Sites (1)

Universitas Hasanuddin

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 35011099 RESULT

Related 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

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nadirah R. Ridha, Dr

  Hasanuddin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Paediatrician

Model Details: 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).

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 28, 2023
• Study Start: March 30, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)