AnemiaNCT06318858
Daily and Weekly Iron Supplementation in Infants
A study testing Iron supplement in people with Anemia and Iron Status, run by Mahidol University at 1 site in Thailand.
Trial summary
This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Status, Infants
- What is being tested?
- Iron supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2023to 14 May 2025
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy infant, aged 6 months ± 2 weeks
- Having a birth weight between 2,500 and 4,000 grams
- Being born full term (37 to 41 weeks of age + 6 days)
- Having hemoglobin ≥ 10.5 g/dL
- Being planned to breastfeed with complementary food and/or complementary foods with formula milk
Who cannot join
- Infants with chronic illnesses or thalassemia clinical signs such as anemia, enlarged liver, or spleen (if parental history suggests the child is at risk of developing a thalassemia disease that may not show clinical symptoms)
- Previously or currently taking an iron supplement
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Samphran District Hospital
Sam Phran, Changwat Nakhon Pathom, 73110
About this study
Official title: Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months
This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months.
Read the detailed description
This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Normal birth weight and term infants will be enrolled at 6 months based on the inclusion criteria. Eligible participants will be assessed at baseline, including anthropometry, dietary intake, and biochemistry (hemoglobin, iron status, vitamin A status, and inflammation). Participants will then be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months. Participants will be followed up at 9 months for the same assessments and will receive weekly iron supplementation for another 3 months. Participants will be followed up at 12 months and the same assessments will be performed. After that, participants will go back to the routine health care service, weekly iron supplementation.
- Conditions
- Anemia, Iron Status, Infants, Iron
- Being tested
- Iron supplement
- Keywords
- Anemia, Iron status, Infants, Iron supplementation
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron supplementDietary supplement
Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old
| Study group | Role | What they receive |
|---|---|---|
| Group 1 daily iron supplementation | Experimental | 12.5 mg daily iron syrup supplementation from 6-9 months old, followed by 12.5 mg weekly iron syrup supplementation from 9-12 months old.
Infants aged 6-9 months will receive two iron syrup bottles. One bottle aims for ingestion every Monday of the week, and one bottle aims for ingestion on other days of the week.
At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week. Receives: Dietary Supplement: Iron supplement |
| Group 2 weekly iron supplementation | Other | 12.5 mg weekly iron syrup supplementation from 6-12 months old. Infants aged 6-9 months will receive an iron syrup bottle that aims for ingestion every Monday of the week and a placebo bottle that aims for ingestion on other days of the week.
At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week. Receives: Dietary Supplement: Iron supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia status
Hemoglobin concentration will be assessed and classified as anemia or non-anemia.
Measured: at aged 6, 9, and 12 months
Iron status
Serum ferritin will be assessed to reflect iron status
Measured: at aged 6, 9, and 12 months
Secondary outcomes (4)
Weight
Body weight will be assessed, and weight-for-age and weight-for-length Z scores will be generated
Measured: at aged 6, 9, and 12 months
Length
Length will be assessed, and length-for-age Z scores and weight-for-length will be generated
Measured: at aged 6, 9, and 12 months
Dietary intake
Dietary intake will be assessed using the 24-hr dietary recall for 3 days
Measured: at aged 6, 9, and 12 months
Head circumference (HC)
HC will be assessed, and head circumference-for-age Z scores will be generated
Measured: at aged 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start15 Mar 2023
- Primary completion25 Oct 2024
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Suranaree University of Technology
- Responsible party
- Sponsor
- Investigators
- Tippawan Pongcharoen, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318858
- Sponsor's protocol ID
- MU-CIRB 2022/313.1411
- Status last verified
- May 2026
- First submitted
- 13 Mar 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No