Iron Deficiency, Anaemia in ChildrenNCT05878379
Effect of a Dietary Iron Program on Iron Status and IQ in Children in Phatthalung Province, Thailand
A study testing Dietary Iron Program in people with Iron Deficiency, Anaemia in Children, run by Mahidol University at 1 site in Thailand.
Trial summary
Iron deficiency (ID) continues to be one of the most prevalent disorders, which can adversely affect cognitive ability in childhood. Our aim was to determine the effect of a dietary iron education program (DIP) on children's iron status and intelligence quotient (IQ) score. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anaemia in Children
- What is being tested?
- Dietary Iron Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- 2 May 2018to 30 Oct 2018
- 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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who were studying in grades 4 and 5 of the selected school
Who cannot join
- Severe illness, including severe anemia (hemoglobin <4.96 mmol/L or <80 g/L)
- Post-menarche
- Use of vitamin or mineral supplements up to 30 days before program implementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Dietary Iron Program on Iron Status and Cognitive Function Amoung School Children in Phatthalung Province, Southern Thailand
Iron deficiency (ID) continues to be one of the most prevalent disorders, which can adversely affect cognitive ability in childhood. Our aim was to determine the effect of a dietary iron education program (DIP) on children's iron status and intelligence quotient (IQ) score. This pre-test (week 1) post-test (week 16) quasi-experimental study with follow-up (week 18) utilized constructs from the Health Belief Model. Children and caregivers participated in the DIP which incorporated group talks, presentations, brainstorming, game-based learning and cooking sessions from weeks 2-15. Knowledge of ID and dietary iron, perceived susceptibility and severity, benefits and barriers for changing behavior, dietary intake, iron status and IQ score were determined at all timepoints (weeks 1, 16, and 18).
Read the detailed description
- Objective The objective of this study was to determine whether an education-based dietary iron program that involved school teachers, parents and children could increase iron status and intelligence quotient (IQ) score in a group of schoolchildren.
- Methods
2.1 Study design A quasi-experimental study (pre-test post-test design with follow-up) was used in this study that was based on the Health Belief Model as its theoretical framework.
2.2 Study Setting and Participants Child-parent/caregiver dyads were recruited from one purposively selected government-administered primary school in Phatthalung province. Schools were not involved in any other programs, located in a rural area, and had at least 200 children studying in grades 4-5. Hookworm screening was done 6 weeks before program implementation by the local government screening program. All children who were studying in grades 4-5 in the selected school were invited to participate. Out of 190 children, 34 children who were mildly anemic were enrolled in the study, together with their parents/caregivers. Sample size was calculated based on serum ferritin concentrations among school-aged children from a study by Rahman et al. [17]. Informed written consent was obtained from child-parent/caregiver dyads prior to program implementation.
2.3 Procedure for the intervention The Health Belief Model underpinned the development of the dietary iron program, which focused on the importance of adequate dietary iron consumption and emphasized prevention of iron deficiency (ID) and iron deficiency anemia (IDA). It was implemented from weeks 2 to 15 of the study. Child-parent/caregiver dyads and teachers received an ID/IDA booklet that included information about anemia, causes of ID, iron-rich food, iron concentration in traditional foods, dietary enhancers and inhibitors of iron absorption, and recipes for iron-rich local and culturally appropriate meals for teachers, parents/caregivers and children, as part of the dietary iron program.
Teachers who were involved in school lunch design participated for discussing and planning iron-rich school lunch menus, and observed teaching and learning process with the use of media and games during the iron lessons for children. Four lessons were conducted for parents/caregivers. The first lesson was discussion that addressed parental perceptions about children's susceptibility to ID and IDA and the severity of ID and IDA concerning cognitive function. In the second lesson, parents/caregivers were asked to list the benefits and barriers for changing behavior with regards to preparing more iron-rich foods in the home. Then, the principal researcher invited parents/caregivers to brainstorm and share ways to overcome these barriers. Cooking classes for preparing iron-rich meals at home were conducted. Parents/caregivers voted for two iron-rich meals that they wanted to cook and then they prepared and cooked them in the classes. For the final lesson, the principal researcher visited each parent/caregiver to discuss the barriers they faced when trying to incorporate more iron-rich meals into their child's diet at home. Three lessons were conducted for the children, one per month. In the first lesson, group talks and games were used to engage the children about the causes and effects of ID and IDA. The second lesson focused on iron-rich food. After that, the children partook in games that entailed writing names of food ingredients that contained iron and circling pictures of iron-rich foods, and describing the sensations associated with consuming these foods. Both positive and negative answers from children were selected for discussion, and approaches for consuming more iron-rich food were brainstormed. A market assignment was set to help the children remember the names of iron-rich food and recognize the foods when they visited a market with their parents. The last lesson was a cooking class. After each cooking class finished, the researcher and a teacher encouraged them to eat this meal together.
2.4 Measurement outcomes The main outcome for this study was the effect of an education-based dietary iron program on iron status and intelligence quotient (IQ) score among children before program implementation (week 1) and at week 16 (immediately after program implementation) and at 18 weeks (follow-up appointment to determine the sustainability of the intervention). All of the outcome variables were measured at different time points. Children's knowledge towards ID and IDA was determined using a questionnaire, while children's iron intake was estimated by using three days of 24-hour recalls (2 school days and 1 weekend day). Portion sizes were estimated by using household portion sizes (rice-serving spoon, tablespoon, teaspoon and glass). IQ score was measured by a trained child psychologist by using the Standard Progressive Matrices (SPM) parallel version. Iron status was determined from blood samples drawn by medical technologists in the first-aid rooms. Concentration of hemoglobin, serum ferritin and serum C-reactive protein were measured by laboratory staff at hematology laboratory at N-health laboratory, Bangkok Dusit Medical Service Hospital (BDMS), Songkla province, using the hemoglobin assay kit (Colorimetric), chemiluminescent immunoassay (CMIA) and high-sensitivity C-reactive protein methods, respectively. Iron status was defined iron-replete: hemoglobin >115 g/l and serum ferritin level > 30 µg/l; anemia: hemoglobin <115 g/l and serum ferritin level >30 µg/l; mild-moderate iron depletion with anemia: hemoglobin 80-114 g/l and serum ferritin level <30 µg/l.; mild iron depletion without anemia: serum ferritin level < 30 µg/l and hemoglobin>115 g/l. In addition, parents/caregivers were assessed by using a questionnaire toward knowledge and perceptions consisted of perceived susceptibility, severity, benefits and barriers in relation to ID and IDA.
2.5 Data Analysis Data from questionnaires were recorded using EpiData version 3.1, while 24-hour dietary recall data were entered into INMUCAL V3, which is a nutrient composition database of dietary items commonly consumed in Thailand. Portion sizes were converted into grams before entering data, and energy and nutrient intakes were calculated. Statistical analysis was carried out by using SPSS version 18. Frequencies, percentage, mean (SD) and median (25th-75th percentile) were calculated for demographic characteristics of participant knowledge, perceptions, iron intake, iron status, and IQ score. The One-Way Repeated Measures ANOVA and Friedman's Two-Way Analysis of Variance by Ranks were used to compare mean differences in knowledge score and perception score of IDA and ID prevention among parents/caregivers, total iron intake, heme iron intake, non-heme iron intake, iron status and IQ score among children at different time points. The Monte Carlo exact test was used to compare the number of children in grades 4-5 who met/did not meet the Thai DRI for iron at pre-test, post-test and follow-up. Differences were considered to be significantly different when p<0.05.
2.6 Ethical approval The study was granted ethical approval by the Committee of the Ethical Review for Human Research, Faculty of Public Health, Mahidol University Thailand 9 March 2018 (COA. No. MUPH 2018-048).
- Conditions
- Iron Deficiency, Anaemia in Children
- Being tested
- Dietary Iron Program
- Keywords
- Iron deficiency, Iron status, Cognitive function, education
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Iron ProgramBehavioural
Teachers Lesson 1: Discuss about causes, prevention and effects of anemia and ID, dietary iron, dietary enhancers and inhibitors of iron absorption, and school lunch menu Lesson 2: Participate in and observe how to teach children in an iron curriculum
Caregivers Lesson 1: Presentation and group talk about causes, prevention, and effects of anemia and ID, dietary iron, and dietary enhancers and inhibitors of iron absorption Lesson 2: Discuss benefits and barriers of changing to an iron-rich meal at home Lesson 3: Cooking class for preparing an iron-rich meal at home (2 times) Lesson 4: Home visit
Children Lesson 1: Group talk about causes and effects of anemia and ID Games: "Where are you from?" Lesson 2: Presentation and group talk about dietary iron, and dietary enhancers and inhibitors of iron absorption, and iron-rich food Games: "What is the winner?" Assignment: Market assignment Lesson 3: Cooking class (2 times)
| Study group | Role | What they receive |
|---|---|---|
| Dietary Iron Program | Experimental | The dietary iron program was administered from weeks 2 to 15 in between pre-test and post-test measurements Receives: Behavioral: Dietary Iron Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Status
For outcome 1, individuals were categorized as either: (1.) iron replete, (2.) Iron deficient, (3.) Iron deficient with mild-moderate anemia (4.) mild-moderately anemic
Measured: Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)
Secondary outcomes (1)
Intelligence quotient (IQ) score
Outcome 2 was measured as the number of IQ points (continuous data)
Measured: Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start2 May 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental (pre-test post-test) design with follow-up / Behavioral intervention, based on the Health Belief Model
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Witchada Simla, MSc, Principal investigator, Thaksin University (Phatthalung Campus), Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878379
- Sponsor's protocol ID
- MUPH 2018-048
- Status last verified
- May 2023
- First submitted
- 5 Apr 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be shared with researchers outside of the research team.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Dietary Iron Program on Iron Status and Cognitive Function Amoung School Children in Phatthalung Province, Southern Thailand
- ClinicalTrials.gov ID
- NCT05878379
- Acronym / sponsor ID
- MUPH 2018-048
- Conditions
- Iron Deficiency, Anaemia in Children
- Keywords
- Iron deficiency, Iron status, Cognitive function, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 26 May 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 deficiency (ID) continues to be one of the most prevalent disorders, which can adversely affect cognitive ability in childhood. Our aim was to determine the effect of a dietary iron education program (DIP) on children's iron status and intelligence quotient (IQ) score. This pre-test (week 1) post-test (week 16) quasi-experimental study with follow-up (week 18) utilized constructs from the Health Belief Model. Children and caregivers participated in the DIP which incorporated group talks, presentations, brainstorming, game-based learning and cooking sessions from weeks 2-15. Knowledge of ID and dietary iron, perceived susceptibility and severity, benefits and barriers for changing behavior, dietary intake, iron status and IQ score were determined at all timepoints (weeks 1, 16, and 18).
Detailed description
- Objective The objective of this study was to determine whether an education-based dietary iron program that involved school teachers, parents and children could increase iron status and intelligence quotient (IQ) score in a group of schoolchildren.
- Methods
2.1 Study design A quasi-experimental study (pre-test post-test design with follow-up) was used in this study that was based on the Health Belief Model as its theoretical framework.
2.2 Study Setting and Participants Child-parent/caregiver dyads were recruited from one purposively selected government-administered primary school in Phatthalung province. Schools were not involved in any other programs, located in a rural area, and had at least 200 children studying in grades 4-5. Hookworm screening was done 6 weeks before program implementation by the local government screening program. All children who were studying in grades 4-5 in the selected school were invited to participate. Out of 190 children, 34 children who were mildly anemic were enrolled in the study, together with their parents/caregivers. Sample size was calculated based on serum ferritin concentrations among school-aged children from a study by Rahman et al. [17]. Informed written consent was obtained from child-parent/caregiver dyads prior to program implementation.
2.3 Procedure for the intervention The Health Belief Model underpinned the development of the dietary iron program, which focused on the importance of adequate dietary iron consumption and emphasized prevention of iron deficiency (ID) and iron deficiency anemia (IDA). It was implemented from weeks 2 to 15 of the study. Child-parent/caregiver dyads and teachers received an ID/IDA booklet that included information about anemia, causes of ID, iron-rich food, iron concentration in traditional foods, dietary enhancers and inhibitors of iron absorption, and recipes for iron-rich local and culturally appropriate meals for teachers, parents/caregivers and children, as part of the dietary iron program.
Teachers who were involved in school lunch design participated for discussing and planning iron-rich school lunch menus, and observed teaching and learning process with the use of media and games during the iron lessons for children. Four lessons were conducted for parents/caregivers. The first lesson was discussion that addressed parental perceptions about children's susceptibility to ID and IDA and the severity of ID and IDA concerning cognitive function. In the second lesson, parents/caregivers were asked to list the benefits and barriers for changing behavior with regards to preparing more iron-rich foods in the home. Then, the principal researcher invited parents/caregivers to brainstorm and share ways to overcome these barriers. Cooking classes for preparing iron-rich meals at home were conducted. Parents/caregivers voted for two iron-rich meals that they wanted to cook and then they prepared and cooked them in the classes. For the final lesson, the principal researcher visited each parent/caregiver to discuss the barriers they faced when trying to incorporate more iron-rich meals into their child's diet at home. Three lessons were conducted for the children, one per month. In the first lesson, group talks and games were used to engage the children about the causes and effects of ID and IDA. The second lesson focused on iron-rich food. After that, the children partook in games that entailed writing names of food ingredients that contained iron and circling pictures of iron-rich foods, and describing the sensations associated with consuming these foods. Both positive and negative answers from children were selected for discussion, and approaches for consuming more iron-rich food were brainstormed. A market assignment was set to help the children remember the names of iron-rich food and recognize the foods when they visited a market with their parents. The last lesson was a cooking class. After each cooking class finished, the researcher and a teacher encouraged them to eat this meal together.
2.4 Measurement outcomes The main outcome for this study was the effect of an education-based dietary iron program on iron status and intelligence quotient (IQ) score among children before program implementation (week 1) and at week 16 (immediately after program implementation) and at 18 weeks (follow-up appointment to determine the sustainability of the intervention). All of the outcome variables were measured at different time points. Children's knowledge towards ID and IDA was determined using a questionnaire, while children's iron intake was estimated by using three days of 24-hour recalls (2 school days and 1 weekend day). Portion sizes were estimated by using household portion sizes (rice-serving spoon, tablespoon, teaspoon and glass). IQ score was measured by a trained child psychologist by using the Standard Progressive Matrices (SPM) parallel version. Iron status was determined from blood samples drawn by medical technologists in the first-aid rooms. Concentration of hemoglobin, serum ferritin and serum C-reactive protein were measured by laboratory staff at hematology laboratory at N-health laboratory, Bangkok Dusit Medical Service Hospital (BDMS), Songkla province, using the hemoglobin assay kit (Colorimetric), chemiluminescent immunoassay (CMIA) and high-sensitivity C-reactive protein methods, respectively. Iron status was defined iron-replete: hemoglobin >115 g/l and serum ferritin level > 30 µg/l; anemia: hemoglobin <115 g/l and serum ferritin level >30 µg/l; mild-moderate iron depletion with anemia: hemoglobin 80-114 g/l and serum ferritin level <30 µg/l.; mild iron depletion without anemia: serum ferritin level < 30 µg/l and hemoglobin>115 g/l. In addition, parents/caregivers were assessed by using a questionnaire toward knowledge and perceptions consisted of perceived susceptibility, severity, benefits and barriers in relation to ID and IDA.
2.5 Data Analysis Data from questionnaires were recorded using EpiData version 3.1, while 24-hour dietary recall data were entered into INMUCAL V3, which is a nutrient composition database of dietary items commonly consumed in Thailand. Portion sizes were converted into grams before entering data, and energy and nutrient intakes were calculated. Statistical analysis was carried out by using SPSS version 18. Frequencies, percentage, mean (SD) and median (25th-75th percentile) were calculated for demographic characteristics of participant knowledge, perceptions, iron intake, iron status, and IQ score. The One-Way Repeated Measures ANOVA and Friedman's Two-Way Analysis of Variance by Ranks were used to compare mean differences in knowledge score and perception score of IDA and ID prevention among parents/caregivers, total iron intake, heme iron intake, non-heme iron intake, iron status and IQ score among children at different time points. The Monte Carlo exact test was used to compare the number of children in grades 4-5 who met/did not meet the Thai DRI for iron at pre-test, post-test and follow-up. Differences were considered to be significantly different when p<0.05.
2.6 Ethical approval The study was granted ethical approval by the Committee of the Ethical Review for Human Research, Faculty of Public Health, Mahidol University Thailand 9 March 2018 (COA. No. MUPH 2018-048).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental (pre-test post-test) design with follow-up / Behavioral intervention, based on the Health Belief Model
| Arm | Type | Receives |
|---|---|---|
| Dietary Iron Program | Experimental | Behavioral: Dietary Iron ProgramThe dietary iron program was administered from weeks 2 to 15 in between pre-test and post-test measurements |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who were studying in grades 4 and 5 of the selected school
Key exclusion criteria (3 listed)
- Severe illness, including severe anemia (hemoglobin <4.96 mmol/L or <80 g/L)
- Post-menarche
- Use of vitamin or mineral supplements up to 30 days before program implementation
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 |
|---|---|---|
| Dietary Iron ProgramTeachers Lesson 1: Discuss about causes, prevention and effects of anemia and ID, dietary iron, dietary enhancers and inhibitors of iron absorption, and school lunch menu Lesson 2: Participate in and observe how to teach children in an iron curriculum Caregivers Lesson 1: Presentation and group talk about causes, prevention, and effects of anemia and ID, dietary iron, and dietary enhancers and inhibitors of iron absorption Lesson 2: Discuss benefits and barriers of changing to an iron-rich meal at home Lesson 3: Cooking class for preparing an iron-rich meal at home (2 times) Lesson 4: Home visit Children Lesson 1: Group talk about causes and effects of anemia and ID Games: "Where are you from?" Lesson 2: Presentation and group talk about dietary iron, and dietary enhancers and inhibitors of iron absorption, and iron-rich food Games: "What is the winner?" Assignment: Market assignment Lesson 3: Cooking class (2 times) | Behavioural | Dietary Iron Program |
Primary outcome
Iron Status
Time frame: Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)
For outcome 1, individuals were categorized as either: (1.) iron replete, (2.) Iron deficient, (3.) Iron deficient with mild-moderate anemia (4.) mild-moderately anemic
1 secondary outcome
Intelligence quotient (IQ) score
Time frame: Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)
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 26 May 2023.
- Individual participant dataSharing planned: No. IDP will not be shared with researchers outside of the research team.
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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.
Witchada Simla, MSc principal investigator
Thaksin University (Phatthalung Campus), Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Iron Program in people with Iron Deficiency, Anaemia in Children, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 3 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 26 May 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 Thailand. 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?
Iron Status (time frame: Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2023.