Anemia, Iron DeficiencyIronVitANCT04137354
Iron and Vitamin A in School Children
A study testing Intermittent iron supplement and High-dose Vitamin A supplement in people with Anemia, Iron Deficiency and Vitamin A Deficiency, run by University Ghent at 1 site in Ethiopia.
Trial summary
The WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency, Vitamin A Deficiency, Cognitive Development
- What is being tested?
- Intermittent iron supplement and High-dose Vitamin A supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- 1 siteEthiopia
- Study dates
- 2 Nov 2020to 28 Dec 2021
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- One or both their parents signed informed consent form;
- Their parents planned to stay during the period of the study (for the full academic year) in the kebele; and
- They accept of the intervention package including blood draw and home visits. School children with severe anemia (Hb concentration <80 g/L) will be treated by conventional protocol for three months at nearby health centres. After reassessing their haemoglobin concentrations, they can be assigned to their intervention groups if they become eligible as described above.
Who cannot join
- Chronically ill children like diagnosed diabetic and asthma
- Severely under nourished children (defined as body mass index z-score <-3 standard deviations of the median WHO reference population)
- Those who are treated for tuberculosis or suspected to have tuberculosis
- Children with diagnosed haemoglobinopathy (sickle cell and thalassemias)
- Children with night blindness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.
The WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing.
The investigators will evaluate the effectiveness of intermittent iron and vitamin A supplementation on cognitive development and anemia and iron status of Rural Ethiopian school children.
Read the detailed description
Iron deficiency is the commonest micronutrient deficiency worldwide and the major cause of specific anemia - iron deficiency anemia. Iron is an essential mineral with lots of functions in the human body; its deficiency is associated with cognitive impairment, emotional alteration, and altered homeostasis in myelination and neurotransmission. Vitamin A deficiency can lead to anemia, weakened resistance to infection, blindness, and death. Animal model studies showed that vitamin A could affect cognition. Cognitive skills, influenced by cognitive development of the individual, are related with academic performance of the student and long-term success. One target of the Sustainable Development Goals (SDG 4) is to ensure inclusive and equitable quality education and promote lifelong learning opportunities for all. Poor health and undernutrition of children in Low- and Middle-Income Countries (LMIC) are the major limitations to reach their potential school performance and learning skills. The evidence on the role of intermittent iron supplementation in preventing anemia is strong but several aspects of cognitive development, co-supplementation with other micronutrients such as vitamin A are missing.
The aim of this study is to evaluate the effectiveness of intermittent iron and high-dose vitamin A supplementation integrated within school nutritional plan on anemia, iron status and cognitive development of school children (7 - 10 year old) who live in areas with high rates of food insecurity in Ethiopia.
Method: The study will be carried out at primary schools in Arba Minch Zuria District, Ethiopia in children aged from 7 to 10 years. Eligible children (a total of 504 children) will be randomly assigned to one of the four groups: 1) Control placebo receiving placebo vitamin A and placebo iron supplement; 2) Vitamin A group will receive a high dose vitamin A capsule (200,000 IU) and placebo iron supplement.;3) Iron group will receive weekly iron supplementation (42 mg of elemental iron) and placebo vitamin A; and 4)Iron-vitamin A group will receive a combined weekly iron supplementation and high dose vitamin A.
Iron supplements (42mg of elemental iron)/placebo will be given to school chidlren weekly for 10 months and 200,000 IU of vitamin A/placebo will be given at baseline and after 5 months.
- Conditions
- Anemia, Iron Deficiency, Vitamin A Deficiency, Cognitive Development, Helminthic Infection
- Being tested
- Intermittent placebo iron supplement, Intermittent iron supplement, Placebo Vitamin A, High-dose Vitamin A supplement
- Keywords
- Intermittent Iron supplementation, Vitamin A, Cognitive Development, Anemia
- Medical subject headings
- Anemia, Iron-Deficiency, Vitamin A Deficiency, Trematode Infections, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent placebo iron supplementOther
Also called Control iron
Placebo iron supplements are also three tablets containing the same ingredients as for iron tablets and will be given to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months)
Intermittent iron supplementOther
Also called Experimental iron
Three iron tablets containing 42 mg of elemental iron will be provided to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months)
Placebo Vitamin AOther
Also called Control Vitamin A
Children will receive in a colorful Eppendorf tube 400 micro-liter of corn oil stabilized with vitamin A twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months).
High-dose Vitamin A supplementOther
Also called Experimental Vitamin A
Children will receive in a colorful Eppendorf tube 400 micro-liter of oil-based preparation of retinyl palmitate that contains the equivalent of 100,000 IU (110μmol) of vitamin A and stabilized with 20IU of vitamin E twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months).
| Study group | Role | What they receive |
|---|---|---|
| Control Iron&Vitamin A Placebo | Placebo comparator | Children randomly assigned to the placebo iron \& vitamin A control group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months). Receives: Other: Intermittent placebo iron supplement; Other: Placebo Vitamin A |
| Vitamin A & Placebo Iron Supplements | Experimental | Children is this group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive a high dose vitamin A capsule (200,000IU) at baseline and after 4.5 months (at mid-line) Receives: Other: Intermittent placebo iron supplement; Other: High-dose Vitamin A supplement |
| Intermittent Iron Supplements & Placebo Vitamin A | Experimental | Children is this group will receive weekly three tablets of iron (42mg of elemental iron once a week) for 9 months (equivalent to a one school year).
They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months). Receives: Other: Intermittent iron supplement; Other: Placebo Vitamin A |
| Intermittent Iron Supplements & High dose Vitamin A | Experimental | Combined weekly iron supplementation (42mg of elemental iron once a week) for 9 months and high dose vitamin A (200,000IU) at baseline and after 4.5 months (mid-line). Receives: Other: Intermittent iron supplement; Other: High-dose Vitamin A supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory span
Digit span (forward and backward) is a standardized test that assess the working memory of the children, one indicator of cognitive development
Measured: Memory span of the children will be assessed at 9 months
Spatial exploration and awareness
Vision search using cancellation task of the children, the second indicator of cognitive development
Measured: Spatial exploration and awareness of the children will be assessed at 9 months
Reasoning ability
Raven's colored progressive matrices, the third indicator of cognitive development
Measured: The reasoning ability of the children will be assessed at 9 months
Anemia
Hemoglobin concentrations (g/dL)
Measured: Hemoglobin concentrations of children will be assessed at 9 months
Plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Measured: Plasma ferritin is assessed in all children at 9 months
Soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Measured: Soluble transferrin receptor is assessed in all children at 9 months
Secondary outcomes (5)
Serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status of children
Measured: Retinol concentrations will be assessed in all children at 9 months
Serum concentrations in vitamin B12
Serum concentrations in vitamin B12
Measured: Vitamin B12 concentrations will be assessed in all children at 9 months
Prevalence of soil-transmitted helminths
The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms).
Measured: The prevalence of soil-transmitted helminths will be assessed at 4.5 months and at 9 months
Prevalence of Schistosome infection
The prevalence of Schistosoma mansoni infection
Measured: Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months
Adherence to the iron/placebo supplements
Adherence to the tablets of Iron/Placebo will be assessed through teacher's reports. Teachers are the ones who are providing the supplements in a weekly basis.
Measured: Weekly for the whole period of the intervention of 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start2 Nov 2020
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- In randomized placebo-control trial eligible primary school children in the Arba Minch HDSS will be randomly assigned to four groups of treatment in a factorial 2x2 design: 1. A control placebo receiving placebo vitamin A at baseline and after 5 months, and placebo iron supplement weekly; 2. A high dose vitamin A at baseline and after 5 months and weekly placebo iron supplement; 3. Weekly iron supplementation for 10 months and placebo vitamin A at baseline and after 5 months; 4. Combined weekly iron supplementation and high dose vitamin A at baseline and after 5 months. At the end of the study, and if the results are positive, children who receive the placebo iron supplement will receive weekly iron supplementation (42mg of elemental iron once a week) for 10 months. Children in all the treatment groups remain eligible to benefit from the standard health care and nutrition programs provided at school, such as deworming at the beginning of the school year
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, Md. PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137354
- Sponsor's protocol ID
- EC/2019/1289
- Acronym
- IronVitA
- Status last verified
- Mar 2023
- First submitted
- 14 Oct 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary. Data on helminthic infection will use characteristics of the attended schools, villages and of the child (date of birth).
Publications
Guideline: Intermittent Iron Supplementation in Preschool and School-Age Children. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK179850/
PubMed 24479203De-Regil LM, Jefferds ME, Sylvetsky AC, Dowswell T. Intermittent iron supplementation for improving nutrition and development in children under 12 years of age. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD009085. doi: 10.1002/14651858.CD009085.pub2.
PubMed 22161444Friis H, Mwaniki D, Omondi B, Muniu E, Magnussen P, Geissler W, Thiong'o F, Michaelsen KF. Serum retinol concentrations and Schistosoma mansoni, intestinal helminths, and malarial parasitemia: a cross-sectional study in Kenyan preschool and primary school children. Am J Clin Nutr. 1997 Sep;66(3):665-71. doi: 10.1093/ajcn/66.3.665.
PubMed 9280190Zimmermann MB, Biebinger R, Rohner F, Dib A, Zeder C, Hurrell RF, Chaouki N. Vitamin A supplementation in children with poor vitamin A and iron status increases erythropoietin and hemoglobin concentrations without changing total body iron. Am J Clin Nutr. 2006 Sep;84(3):580-6. doi: 10.1093/ajcn/84.3.580.
PubMed 16960172Mwaniki D, Omondi B, Muniu E, Thiong'o F, Ouma J, Magnussen P, Geissler PW, Michaelsen KF, Friis H. Effects on serum retinol of multi-micronutrient supplementation and multi-helminth chemotherapy: a randomised, controlled trial in Kenyan school children. Eur J Clin Nutr. 2002 Jul;56(7):666-73. doi: 10.1038/sj.ejcn.1601376.
PubMed 12080408Gutema BT, Tariku EZ, Melketsedik ZA, Levecke B, De Henauw S, Abubakar A, Abbeddou S. Assessing the influence of COVID-19 lockdown measures on cognition and behavior in school age children in Arba Minch Health and Demographic Surveillance site, Southern Ethiopia: A cross-sectional study. PLOS Glob Public Health. 2024 Mar 21;4(3):e0002978. doi: 10.1371/journal.pgph.0002978. eCollection 2024.
PubMed 38512931Gutema BT, Levecke B, Sorrie MB, Megersa ND, Zewdie TH, Yesera GE, De Henauw S, Abubakar A, Abbeddou S. Effectiveness of intermittent iron and high-dose vitamin A supplementation on cognitive development of school children in southern Ethiopia: a randomized placebo-controlled trial. Am J Clin Nutr. 2024 Feb;119(2):470-484. doi: 10.1016/j.ajcnut.2023.11.005. Epub 2023 Nov 11.
PubMed 37952928
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.
- ClinicalTrials.gov ID
- NCT04137354
- Acronym / sponsor ID
- IronVitA / EC/2019/1289
- Conditions
- Anemia, Iron Deficiency, Vitamin A Deficiency, Cognitive Development, Helminthic Infection
- Keywords
- Intermittent Iron supplementation, Vitamin A, Cognitive Development, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 24 Oct 2019 (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.
The WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing.
The investigators will evaluate the effectiveness of intermittent iron and vitamin A supplementation on cognitive development and anemia and iron status of Rural Ethiopian school children.
Detailed description
Iron deficiency is the commonest micronutrient deficiency worldwide and the major cause of specific anemia - iron deficiency anemia. Iron is an essential mineral with lots of functions in the human body; its deficiency is associated with cognitive impairment, emotional alteration, and altered homeostasis in myelination and neurotransmission. Vitamin A deficiency can lead to anemia, weakened resistance to infection, blindness, and death. Animal model studies showed that vitamin A could affect cognition. Cognitive skills, influenced by cognitive development of the individual, are related with academic performance of the student and long-term success. One target of the Sustainable Development Goals (SDG 4) is to ensure inclusive and equitable quality education and promote lifelong learning opportunities for all. Poor health and undernutrition of children in Low- and Middle-Income Countries (LMIC) are the major limitations to reach their potential school performance and learning skills. The evidence on the role of intermittent iron supplementation in preventing anemia is strong but several aspects of cognitive development, co-supplementation with other micronutrients such as vitamin A are missing.
The aim of this study is to evaluate the effectiveness of intermittent iron and high-dose vitamin A supplementation integrated within school nutritional plan on anemia, iron status and cognitive development of school children (7 - 10 year old) who live in areas with high rates of food insecurity in Ethiopia.
Method: The study will be carried out at primary schools in Arba Minch Zuria District, Ethiopia in children aged from 7 to 10 years. Eligible children (a total of 504 children) will be randomly assigned to one of the four groups: 1) Control placebo receiving placebo vitamin A and placebo iron supplement; 2) Vitamin A group will receive a high dose vitamin A capsule (200,000 IU) and placebo iron supplement.;3) Iron group will receive weekly iron supplementation (42 mg of elemental iron) and placebo vitamin A; and 4)Iron-vitamin A group will receive a combined weekly iron supplementation and high dose vitamin A.
Iron supplements (42mg of elemental iron)/placebo will be given to school chidlren weekly for 10 months and 200,000 IU of vitamin A/placebo will be given at baseline and after 5 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- In randomized placebo-control trial eligible primary school children in the Arba Minch HDSS will be randomly assigned to four groups of treatment in a factorial 2x2 design: 1. A control placebo receiving placebo vitamin A at baseline and after 5 months, and placebo iron supplement weekly; 2. A high dose vitamin A at baseline and after 5 months and weekly placebo iron supplement; 3. Weekly iron supplementation for 10 months and placebo vitamin A at baseline and after 5 months; 4. Combined weekly iron supplementation and high dose vitamin A at baseline and after 5 months. At the end of the study, and if the results are positive, children who receive the placebo iron supplement will receive weekly iron supplementation (42mg of elemental iron once a week) for 10 months. Children in all the treatment groups remain eligible to benefit from the standard health care and nutrition programs provided at school, such as deworming at the beginning of the school year
| Arm | Type | Receives |
|---|---|---|
| Control Iron&Vitamin A Placebo | Placebo comparator | Other: Intermittent placebo iron supplement, Other: Placebo Vitamin AChildren randomly assigned to the placebo iron \& vitamin A control group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months). |
| Vitamin A & Placebo Iron Supplements | Experimental | Other: Intermittent placebo iron supplement, Other: High-dose Vitamin A supplementChildren is this group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive a high dose vitamin A capsule (200,000IU) at baseline and after 4.5 months (at mid-line) |
| Intermittent Iron Supplements & Placebo Vitamin A | Experimental | Other: Intermittent iron supplement, Other: Placebo Vitamin AChildren is this group will receive weekly three tablets of iron (42mg of elemental iron once a week) for 9 months (equivalent to a one school year). They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months). |
| Intermittent Iron Supplements & High dose Vitamin A | Experimental | Other: Intermittent iron supplement, Other: High-dose Vitamin A supplementCombined weekly iron supplementation (42mg of elemental iron once a week) for 9 months and high dose vitamin A (200,000IU) at baseline and after 4.5 months (mid-line). |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- One or both their parents signed informed consent form;
- Their parents planned to stay during the period of the study (for the full academic year) in the kebele; and
- They accept of the intervention package including blood draw and home visits. School children with severe anemia (Hb concentration <80 g/L) will be treated by conventional protocol for three months at nearby health centres. After reassessing their haemoglobin concentrations, they can be assigned to their intervention groups if they become eligible as described above.
Key exclusion criteria (5 listed)
- Chronically ill children like diagnosed diabetic and asthma
- Severely under nourished children (defined as body mass index z-score <-3 standard deviations of the median WHO reference population)
- Those who are treated for tuberculosis or suspected to have tuberculosis
- Children with diagnosed haemoglobinopathy (sickle cell and thalassemias)
- Children with night blindness
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 |
|---|---|---|
| Intermittent placebo iron supplementAlso: Control ironPlacebo iron supplements are also three tablets containing the same ingredients as for iron tablets and will be given to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months) | Other | Control Iron&Vitamin A Placebo, Vitamin A & Placebo Iron Supplements |
| Intermittent iron supplementAlso: Experimental ironThree iron tablets containing 42 mg of elemental iron will be provided to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months) | Other | Intermittent Iron Supplements & High dose Vitamin A, Intermittent Iron Supplements & Placebo Vitamin A |
| Placebo Vitamin AAlso: Control Vitamin AChildren will receive in a colorful Eppendorf tube 400 micro-liter of corn oil stabilized with vitamin A twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months). | Other | Control Iron&Vitamin A Placebo, Intermittent Iron Supplements & Placebo Vitamin A |
| High-dose Vitamin A supplementAlso: Experimental Vitamin AChildren will receive in a colorful Eppendorf tube 400 micro-liter of oil-based preparation of retinyl palmitate that contains the equivalent of 100,000 IU (110μmol) of vitamin A and stabilized with 20IU of vitamin E twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months). | Other | Intermittent Iron Supplements & High dose Vitamin A, Vitamin A & Placebo Iron Supplements |
Primary outcome
Memory span
Time frame: Memory span of the children will be assessed at 9 months
Digit span (forward and backward) is a standardized test that assess the working memory of the children, one indicator of cognitive development
Spatial exploration and awareness
Time frame: Spatial exploration and awareness of the children will be assessed at 9 months
Vision search using cancellation task of the children, the second indicator of cognitive development
Reasoning ability
Time frame: The reasoning ability of the children will be assessed at 9 months
Raven's colored progressive matrices, the third indicator of cognitive development
Anemia
Time frame: Hemoglobin concentrations of children will be assessed at 9 months
Hemoglobin concentrations (g/dL)
Plasma ferritin
Time frame: Plasma ferritin is assessed in all children at 9 months
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Soluble transferrin receptor
Time frame: Soluble transferrin receptor is assessed in all children at 9 months
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
5 secondary outcomes
Serum concentrations in Vitamin A (retinol)
Time frame: Retinol concentrations will be assessed in all children at 9 months
Serum concentrations in vitamin B12
Time frame: Vitamin B12 concentrations will be assessed in all children at 9 months
Prevalence of soil-transmitted helminths
Time frame: The prevalence of soil-transmitted helminths will be assessed at 4.5 months and at 9 months
Prevalence of Schistosome infection
Time frame: Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months
Adherence to the iron/placebo supplements
Time frame: Weekly for the whole period of the intervention of 9 months.
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 3 Mar 2023.
- Background: PubMed 24479203Guideline: Intermittent Iron Supplementation in Preschool and School-Age Children. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK179850/
- Background: PubMed 22161444De-Regil LM, Jefferds ME, Sylvetsky AC, Dowswell T. Intermittent iron supplementation for improving nutrition and development in children under 12 years of age. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD009085. doi: 10.1002/14651858.CD009085.pub2.
- Background: PubMed 9280190Friis H, Mwaniki D, Omondi B, Muniu E, Magnussen P, Geissler W, Thiong'o F, Michaelsen KF. Serum retinol concentrations and Schistosoma mansoni, intestinal helminths, and malarial parasitemia: a cross-sectional study in Kenyan preschool and primary school children. Am J Clin Nutr. 1997 Sep;66(3):665-71. doi: 10.1093/ajcn/66.3.665.
- Background: PubMed 16960172Zimmermann MB, Biebinger R, Rohner F, Dib A, Zeder C, Hurrell RF, Chaouki N. Vitamin A supplementation in children with poor vitamin A and iron status increases erythropoietin and hemoglobin concentrations without changing total body iron. Am J Clin Nutr. 2006 Sep;84(3):580-6. doi: 10.1093/ajcn/84.3.580.
- Background: PubMed 12080408Mwaniki D, Omondi B, Muniu E, Thiong'o F, Ouma J, Magnussen P, Geissler PW, Michaelsen KF, Friis H. Effects on serum retinol of multi-micronutrient supplementation and multi-helminth chemotherapy: a randomised, controlled trial in Kenyan school children. Eur J Clin Nutr. 2002 Jul;56(7):666-73. doi: 10.1038/sj.ejcn.1601376.
- Derived from this study: PubMed 38512931Gutema BT, Tariku EZ, Melketsedik ZA, Levecke B, De Henauw S, Abubakar A, Abbeddou S. Assessing the influence of COVID-19 lockdown measures on cognition and behavior in school age children in Arba Minch Health and Demographic Surveillance site, Southern Ethiopia: A cross-sectional study. PLOS Glob Public Health. 2024 Mar 21;4(3):e0002978. doi: 10.1371/journal.pgph.0002978. eCollection 2024.
- Derived from this study: PubMed 37952928Gutema BT, Levecke B, Sorrie MB, Megersa ND, Zewdie TH, Yesera GE, De Henauw S, Abubakar A, Abbeddou S. Effectiveness of intermittent iron and high-dose vitamin A supplementation on cognitive development of school children in southern Ethiopia: a randomized placebo-controlled trial. Am J Clin Nutr. 2024 Feb;119(2):470-484. doi: 10.1016/j.ajcnut.2023.11.005. Epub 2023 Nov 11.
- Individual participant dataSharing planned: No. All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary. Data on helminthic infection will use characteristics of the attended schools, villages and of the child (date of birth).
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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.
Stefaan De Henauw, Md. PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent iron supplement and High-dose Vitamin A supplement in people with Anemia, Iron Deficiency and Vitamin A Deficiency, run by University Ghent at 1 site in Ethiopia.
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 3 inclusion and 5 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 3 Mar 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 Ethiopia. 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. Some participants in this study may receive a placebo. 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?
Memory span (time frame: Memory span of the children will be assessed at 9 months). The study lists 6 primary outcomes in all. 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 NCT04137354, which also lists 7 linked publications.
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 3 Mar 2023.