Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia

NCT07892170 | Not Yet Recruiting

• 1 other identifier: UOB-CP-IDA-VITD-2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will evaluate the effect of two vitamin D3 supplementation regimens, administered in addition to oral iron therapy, on hematological and iron status in children aged 6-60 months with confirmed iron deficiency anemia and vitamin D deficiency. Eligible participants will be randomly assigned in a 1:1 ratio to receive oral elemental iron at 3 mg/kg/day plus either vitamin D3 2000 IU/day or vitamin D3 400 IU/day for 12 weeks. The primary outcome will be the between-group difference in mean change in hemoglobin concentration from baseline to Week 12. Secondary outcomes will include changes in serum ferritin, serum 25-hydroxyvitamin D, red blood cell indices, serum iron, total iron-binding capacity, high-sensitivity C-reactive protein, and exploratory serum hepcidin, as well as adherence and adverse events. Participants will receive follow-up assessments at Weeks 2, 4, 8, and 12 to assess adherence, tolerability, adverse events, and concomitant treatments. Laboratory assessments are planned at baseline and Week 12.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Between-Group Difference in Mean Change in Hemoglobin Concentration

  Change in hemoglobin concentration from baseline to Week 12, compared between the two randomized treatment groups.

  Baseline to Week 12.

Secondary Outcomes (11)

• Change in Serum Ferritin

  Baseline to Week 12.

• Change in Serum 25-Hydroxyvitamin D.

  Baseline to Week 12.

• Change in Mean Corpuscular Volume (MCV).

  Baseline to Week 12.

• Change in Mean Corpuscular Hemoglobin (MCH).

  Baseline to Week 12.

• Change in Serum Iron. Description

  Baseline to Week 12.

Study Arms (2)

Iron + Vitamin D3 2000 IU/day

EXPERIMENTAL

Participants will receive oral elemental iron at a dose of 3 mg/kg/day plus vitamin D3 at a dose of 2000 IU/day for 12 weeks.

Drug: Elemental iron; Drug: Vitamin D3 2000 IU/day

Iron + Vitamin D3 400 IU/day

ACTIVE COMPARATOR

Participants will receive oral elemental iron at a dose of 3 mg/kg/day plus vitamin D3 at a dose of 400 IU/day for 12 weeks.

Drug: Elemental iron; Drug: Vitamin D3 400 IU/day

Interventions

Elemental iron DRUG

Oral elemental iron at a dose of 3 mg/kg/day for 12 weeks, administered to participants in both study arms.

Iron + Vitamin D3 2000 IU/day; Iron + Vitamin D3 400 IU/day

Vitamin D3 2000 IU/day DRUG

Oral vitamin D3 at a dose of 2000 IU/day for 12 weeks, administered with oral elemental iron.

Iron + Vitamin D3 2000 IU/day

Vitamin D3 400 IU/day DRUG

Oral vitamin D3 at a dose of 400 IU/day for 12 weeks, administered with oral elemental iron.

Iron + Vitamin D3 400 IU/day

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-60 months.
• Confirmed iron deficiency anemia based on prespecified hemoglobin and iron-status criteria.
• Vitamin D deficiency defined as serum 25-hydroxyvitamin D \[25(OH)D\] below 20 ng/mL.
• Written informed consent provided by a parent or legal guardian.

You may not qualify if:

• Known chronic disease, malabsorption syndrome, or congenital anemia.
• Severe acute malnutrition, defined in the proposal as WAZ below -3 z-scores.
• Current or recent iron or vitamin D supplementation within the preceding 3 months.
• Acute febrile illness or active infection at screening.

Sponsors & Collaborators

• AlFayhaa General Hospital: lead

Study Sites (1)

Basra Maternity and Children Hospital

Basra, Basra Governorate, Iraq

Location

Related Publications (2)

• Razzaq AA, Haider N, Faiz A, Naseer M, Waheed N, Siddiqui HB. Frequency of vitamin D deficiency in children with iron deficiency anaemia and factors associated with vitamin D deficiency. J Pak Med Assoc. 2024 Apr;74(4):626-630. doi: 10.47391/JPMA.8042.

  PMID: 38751252 BACKGROUND

• Rasyid Ridha N, Fikri B, Irwan, Tanjung C, Alfian Zainuddin A, Maulani D, Hardiyanti Putri S. Effectiveness of Combined Vitamin D and Iron Supplementation on Iron Status in Children with Iron Deficiency Anemia: A Randomized Controlled Trial. J Med Invest. 2025;72(3.4):337-342. doi: 10.2152/jmi.72.337.

  PMID: 41183935 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Fatima R Jasim, B.Pharm.

CONTACT

07710568627; fatimarasoul12345@gmail.com

Study Design

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

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups and followed for 12 weeks.

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

IR (1)