Iron Deficiency, Anaemia in ChildrenNCT06148545
Effect of Iron and Vitamin D Supplementation to Iron Status in Iron Deficiency Anemia
A study testing Elemental iron and Elemental iron and Vit D in people with Iron Deficiency, Anaemia in Children, run by Nadirah Rasyid Ridha at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anaemia in Children
- What is being tested?
- Elemental iron and Elemental iron and Vit D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Mar 2023to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of Children's Iron deficiency anemia
- Must be able to drink syrups
Who cannot join
- Patients who have diarrhea
- Patients who experience vomiting
- Severe anemia
- Post Transfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi
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.
Read the detailed description
This research is a randomized controlled trial study conducted in Makassar, South of Sulawesi, Indonesia from April to October 2023. This study was conducted on children with a diagnosis of iron deficiency anemia. 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).
The inclusion criteria in this study were children aged 1-5 years, diagnosed with iron deficiency anemia, and parents/caregivers willing to include their children in this study. Children who had received iron preparation, and previous blood transfusion were excluded in this study. Patients who refused blood tests after giving therapy for 4 weeks were declared dropouts.
Researchers will provide informed consent to parents/caregivers of children who met the research criteria. Anamnesis, general physical examination, and complete blood count (CBC) analysis were carried out: hemoglobin (Hb), Red Blood cell (RBC), Mean erythrocyte volume (MCV), Mean erythrocyte hemoglobin (MCH), Reticulocytes, serum iron, and serum ferritin. Iron deficiency anemia if the level of hemoglobin <11 g/dL, microcytic Hypochromia, serum ferritin < 30 pg/dl, then given iron and vitamin D preparation for 4 weeks, then checked again complete blood count, serum fe and serum ferritin. The research results are recorded in a research form and the data is grouped and SPSS version 21.0 software is used for data analysis. A P value <0.05 was considered for statistical analysis. This study was approved by the ethics and research committee of the faculty of medicine, at Hasanuddin University
- Conditions
- Iron Deficiency, Anaemia in Children
- Being tested
- Elemental iron, Elemental iron and Vit D
- Keywords
- vitamin D, Iron status, Iron deficiency anemia
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental ironDrug
Also called Iron supplementation
Group A who received standard therapy (Fe preparations) 3 mg/kg BW/day
Elemental iron and Vit DDrug
Also called Iron supplementation with Vitamin D
Group B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Elemental iron and Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study was to compare the effect of standard therapy with standard therapy plus vitamin D in children with IDA.
- Comparing pre-treatment routine blood test, serum iron, and serum ferritin levels between iron supplementation and iron and vitamin D supplementation groups.
- 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.
Measured: After 4 weeks
Secondary outcomes (1)
Comparison of mean changes in complete blood count, serum iron, and serum ferritin level
- Comparing the difference in routine blood test results, and ferritin before and after treatment between the iron supplementation group and the iron and vitamin D supplementation group.
- Comparing the difference of routine blood test results, and serum iron ferritin before and after therapy in the iron supplementation group.
- Comparing the difference of routine blood test results, serum iron ferritin before and after therapy in iron supplementation and Vitamin D supplementation groups.
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start30 Mar 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency, Anaemia in ChildrenStudies 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
- 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).
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nadirah Rasyid Ridha
- Sponsor type
- University, hospital or other
- Collaborators
- Hasanuddin University
- Responsible party
- Sponsor-investigator, Nadirah Rasyid Ridha, Hasanuddin University
- Investigators
- Nadirah R. Ridha, Dr, Study chair, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148545
- Sponsor's protocol ID
- UH23020108
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35011099
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi
- ClinicalTrials.gov ID
- NCT06148545
- Acronym / sponsor ID
- UH23020108
- Conditions
- Iron Deficiency, Anaemia in Children
- Keywords
- vitamin D, Iron status, Iron deficiency anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Nadirah Rasyid RidhaUniversity, hospital or other
- Collaborators
- Hasanuddin University
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research is a randomized controlled trial study conducted in Makassar, South of Sulawesi, Indonesia from April to October 2023. This study was conducted on children with a diagnosis of iron deficiency anemia. 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).
The inclusion criteria in this study were children aged 1-5 years, diagnosed with iron deficiency anemia, and parents/caregivers willing to include their children in this study. Children who had received iron preparation, and previous blood transfusion were excluded in this study. Patients who refused blood tests after giving therapy for 4 weeks were declared dropouts.
Researchers will provide informed consent to parents/caregivers of children who met the research criteria. Anamnesis, general physical examination, and complete blood count (CBC) analysis were carried out: hemoglobin (Hb), Red Blood cell (RBC), Mean erythrocyte volume (MCV), Mean erythrocyte hemoglobin (MCH), Reticulocytes, serum iron, and serum ferritin. Iron deficiency anemia if the level of hemoglobin <11 g/dL, microcytic Hypochromia, serum ferritin < 30 pg/dl, then given iron and vitamin D preparation for 4 weeks, then checked again complete blood count, serum fe and serum ferritin. The research results are recorded in a research form and the data is grouped and SPSS version 21.0 software is used for data analysis. A P value <0.05 was considered for statistical analysis. This study was approved by the ethics and research committee of the faculty of medicine, at Hasanuddin University
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Iron supplementation | Experimental | Drug: Elemental ironChildren 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. |
| Iron and Vitamin D supplementation | Experimental | Drug: Elemental iron and Vit DChildren 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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of Children's Iron deficiency anemia
- Must be able to drink syrups
Key exclusion criteria (4 listed)
- Patients who have diarrhea
- Patients who experience vomiting
- Severe anemia
- Post Transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemental ironAlso: Iron supplementationGroup A who received standard therapy (Fe preparations) 3 mg/kg BW/day | Drug | Iron supplementation |
| Elemental iron and Vit DAlso: Iron supplementation with Vitamin DGroup B received standard therapy (Fe preparations) 3 mg/kgBW/day combination with vitamin D, 400IU). | Drug | Iron and Vitamin D supplementation |
Primary outcome
This study was to compare the effect of standard therapy with standard therapy plus vitamin D in children with IDA.
Time frame: After 4 weeks
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.
1 secondary outcome
Comparison of mean changes in complete blood count, serum iron, and serum ferritin level
Time frame: after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Results publication: PubMed 35011099Samson 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.
- The effect of vitamin D supplementation on hemoglobin concentration: a systematic review and meta-analysisLink provided by the sponsor.
- The effect of iron on vitamin D level in children with combined iron and vitamin D deficiencyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadirah R. Ridha, Dr study chair
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elemental iron and Elemental iron and Vit D in people with Iron Deficiency, Anaemia in Children, run by Nadirah Rasyid Ridha at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study was to compare the effect of standard therapy with standard therapy plus vitamin D in children with IDA. (time frame: After 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.