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Not yet recruitingNCT07892170Updated Oct 23, 2026

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

An interventional study of Elemental iron and Vitamin D3 2000 IU/day in Iron Deficiency Anemia, sponsored by AlFayhaa General Hospital. Not yet recruiting at 1 site in Iraq. Open to participants aged 6 Months to 60 Months. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by AlFayhaa General Hospital · Not applicable, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
6 Months to 60 Months
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Iron Deficiency Anemia
03

In context

Anemia, Iron-Deficiency

660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 515 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

AlFayhaa General Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Inclusion Criteria:

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

Exclusion Criteria:

  • Exclusion Criteria:

    1. Known chronic disease, malabsorption syndrome, or congenital anemia.
    2. Severe acute malnutrition, defined in the proposal as WAZ below -3 z-scores.
    3. Current or recent iron or vitamin D supplementation within the preceding 3 months.
    4. Acute febrile illness or active infection at screening.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Iron + Vitamin D3 2000 IU/day

    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

  • Active comparator
    Iron + Vitamin D3 400 IU/day

    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

  • DrugElemental iron

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

  • DrugVitamin D3 2000 IU/day

    Drug page: Cholecalciferol

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

  • DrugVitamin D3 400 IU/day

    Drug page: Cholecalciferol

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

06

What researchers measure

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.

    Time frame: Baseline to Week 12.

Secondary outcomes

  1. Change in Serum Ferritin

    Change in serum ferritin concentration from baseline to Week 12, compared between groups.

    Time frame: Baseline to Week 12.

  2. Change in Serum 25-Hydroxyvitamin D.

    Change in serum 25(OH)D concentration from baseline to Week 12.

    Time frame: Baseline to Week 12.

  3. Change in Mean Corpuscular Volume (MCV).

    Change in MCV from baseline to Week 12.

    Time frame: Baseline to Week 12.

  4. Change in Mean Corpuscular Hemoglobin (MCH).

    Change in MCH from baseline to Week 12.

    Time frame: Baseline to Week 12.

  5. 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.

    Time frame: Baseline to Week 12.

  6. Change in Total Iron-Binding Capacity (TIBC).

    Change in TIBC from baseline to Week 12. Unit: Use the laboratory's reporting unit.

    Time frame: Baseline to Week 12.

  7. Change in Serum Hepcidin.

    Change in serum hepcidin concentration from baseline to Week 12. Unit: Assay-dependent.

    Time frame: Baseline to Week 12.

  8. Change in hsCRP.

    Change in hsCRP concentration from baseline to Week 12, if measured at both visits.

    Time frame: Baseline to Week 12, subject to feasibility.

  9. Resolution of Anemia.

    Proportion of participants meeting the prespecified hemoglobin criterion for anemia resolution at Week 12.

    Time frame: Week 12.

  10. Adherence to Supplementation.

    Adherence to the assigned iron and vitamin D supplementation regimen, assessed using the prespecified adherence method.

    Time frame: Weeks 2, 4, 8, and 12.

  11. Incidence of Adverse Events.

    Proportion of participants experiencing adverse events, including gastrointestinal symptoms, during supplementation.

    Time frame: Weeks 2, 4, 8, and 12.

07

Study locations

1 site
  • Basra Maternity and Children Hospital
    Basra, Basra Governorate, Iraq
08

References and documents

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 38751252 ↗
  • 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. PubMed 41183935 ↗

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.

Of 127 non-industry interventional studies with no phase under Anemia, Iron-Deficiency, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 27. This study's planned 7 months is below that.

Counting every sponsor, half of 139 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2026
First posted
Oct 23, 2026
StartEst.
Oct 2026
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07892170
Lead sponsor
AlFayhaa General Hospital
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Oct 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Fatima R Jasim, B.Pharm.
Contact
fatimarasoul12345@gmail.com
07710568627

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cholecalciferol

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