Iron Deficiency AnemiaNCT07892170
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
A study testing Elemental iron, Vitamin D3 2000 IU/day and Vitamin D3 400 IU/day in people with Iron Deficiency Anemia, run by AlFayhaa General Hospital at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Elemental iron, Vitamin D3 2000 IU/day and Vitamin D3 400 IU/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- Oct 2026to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Concurrent Iron and Vitamin D Deficiencies in Children With Anemia: A Cross-Sectional Analysis and a Randomized Controlled Trial of Combined Supplementation
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.
Read more
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.
Read the detailed description
Iron deficiency anemia and vitamin D deficiency may coexist in young children. This study will investigate the effects of different vitamin D3 supplementation doses when added to standard oral iron therapy.
The trial will use a prospective, open-label, parallel-group randomized design at a single study center. A computer-generated randomization sequence will be used to allocate eligible participants to one of two treatment groups.
The study will also assess changes in hematological parameters, iron status, vitamin D status, inflammatory markers, and exploratory hepcidin concentrations. A clinical pharmacist will contribute to weight-based dose calculation, dispensing documentation, caregiver counselling, adherence assessment, and adverse-event monitoring.
The study findings will estimate the comparative effects of the two supplementation regimens without presuming that either regimen will produce superior outcomes.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Elemental iron, Vitamin D3 2000 IU/day, Vitamin D3 400 IU/day
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental ironDrug
Oral elemental iron at a dose of 3 mg/kg/day for 12 weeks, administered to participants in both study arms.
Vitamin D3 2000 IU/dayDrug
Oral vitamin D3 at a dose of 2000 IU/day for 12 weeks, administered with oral elemental iron.
Vitamin D3 400 IU/dayDrug
Oral vitamin D3 at a dose of 400 IU/day for 12 weeks, administered with oral elemental iron.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Elemental iron; Drug: Vitamin D3 400 IU/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12.
Secondary outcomes (11)
Change in Serum Ferritin
Change in serum ferritin concentration from baseline to Week 12, compared between groups.
Measured: Baseline to Week 12.
Change in Serum 25-Hydroxyvitamin D.
Change in serum 25(OH)D concentration from baseline to Week 12.
Measured: Baseline to Week 12.
Change in Mean Corpuscular Volume (MCV).
Change in MCV from baseline to Week 12.
Measured: Baseline to Week 12.
Change in Mean Corpuscular Hemoglobin (MCH).
Change in MCH from baseline to Week 12.
Measured: Baseline to Week 12.
Change in Serum Iron. Description
Change in serum iron concentration from baseline to Week 12. Unit: µg/dL, if this is the laboratory's reporting unit.
Measured: Baseline to Week 12.
Change in Total Iron-Binding Capacity (TIBC).
Change in TIBC from baseline to Week 12. Unit: Use the laboratory's reporting unit.
Measured: Baseline to Week 12.
Change in Serum Hepcidin.
Change in serum hepcidin concentration from baseline to Week 12. Unit: Assay-dependent.
Measured: Baseline to Week 12.
Change in hsCRP.
Change in hsCRP concentration from baseline to Week 12, if measured at both visits.
Measured: Baseline to Week 12, subject to feasibility.
Resolution of Anemia.
Proportion of participants meeting the prespecified hemoglobin criterion for anemia resolution at Week 12.
Measured: Week 12.
Adherence to Supplementation.
Adherence to the assigned iron and vitamin D supplementation regimen, assessed using the prespecified adherence method.
Measured: Weeks 2, 4, 8, and 12.
Incidence of Adverse Events.
Proportion of participants experiencing adverse events, including gastrointestinal symptoms, during supplementation.
Measured: Weeks 2, 4, 8, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups and followed for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlFayhaa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892170
- Sponsor's protocol ID
- UOB-CP-IDA-VITD-2026
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant-level data has not yet been determined. Any future data-sharing decisions will be made in consultation with the study supervisor and in accordance with ethical approval requirements and participant confidentiality protections.
Publications
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.
PubMed 38751252Rasyid 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.
PubMed 41183935