Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Key facts
- Who runs it
- AlFayhaa General Hospital
- Where
- Iraq1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 120 people, planned
- Started
- Oct 2026
- Expected to end
- May 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Elemental iron
- Vitamin D3 2000 IU/day
- Vitamin D3 400 IU/day
- Record updated
- 30 October 2026
Who can take part
- Age
- 6 months to 60 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Inclusion Criteria:; 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
Who cannot take part
- Exclusion Criteria:; 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Iron + Vitamin D3 2000 IU/dayTreatment being tested
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.
Treatment: Elemental iron and Vitamin D3 2000 IU/day
- Iron + Vitamin D3 400 IU/dayExisting treatment, for comparison
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.
Treatment: Elemental iron and Vitamin D3 400 IU/day
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Concurrent Iron and Vitamin D Deficiencies in Children With Anemia: A Cross-Sectional Analysis and a Randomized Controlled Trial of Combined Supplementation
- Record updated
- 30 October 2026