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Iron and Vitamin A in School Children (IronVitA)

Primary Purpose

Anemia, Iron Deficiency, Vitamin A Deficiency, Cognitive Development

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Intermittent placebo iron supplement
Intermittent iron supplement
Placebo Vitamin A
High-dose Vitamin A supplement
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia, Iron Deficiency focused on measuring Intermittent Iron supplementation, Vitamin A, Cognitive Development, Anemia

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Arba Minch University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control Iron&Vitamin A Placebo

Vitamin A & Placebo Iron Supplements

Intermittent Iron Supplements & Placebo Vitamin A

Intermittent Iron Supplements & High dose Vitamin A

Arm Description

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).

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)

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).

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).

Outcomes

Primary Outcome Measures

Memory span
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
Vision search using cancellation task of the children, the second indicator of cognitive development
Reasoning ability
Raven's colored progressive matrices, the third indicator of cognitive development
Anemia
Hemoglobin concentrations (g/dL)
Plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings

Secondary Outcome Measures

Serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status of children
Serum concentrations in vitamin B12
Serum concentrations in vitamin B12
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).
Prevalence of Schistosome infection
The prevalence of Schistosoma mansoni infection
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.

Full Information

First Posted
October 14, 2019
Last Updated
March 2, 2023
Sponsor
University Ghent
Collaborators
Flemish Interuniversity Council (VLIR), Arba Minch University, Ethiopia
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1. Study Identification

Unique Protocol Identification Number
NCT04137354
Brief Title
Iron and Vitamin A in School Children
Acronym
IronVitA
Official Title
Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Flemish Interuniversity Council (VLIR), Arba Minch University, Ethiopia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency, Vitamin A Deficiency, Cognitive Development, Helminthic Infection
Keywords
Intermittent Iron supplementation, Vitamin A, Cognitive Development, Anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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: A control placebo receiving placebo vitamin A at baseline and after 5 months, and placebo iron supplement weekly; A high dose vitamin A at baseline and after 5 months and weekly placebo iron supplement; Weekly iron supplementation for 10 months and placebo vitamin A at baseline and after 5 months; 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Iron supplements and their placebo: Both iron and placebo supplements will be produced by Metagenics (Belgium) for the context of this study. Placebo tablets will have the same taste, and shape of the iron tablets, the colour is slightly different because of the characteristics of the products but the blinding is ensured. The blister/ the tablets will be packed and only coded. Vitamin A and its placebo: Vitamin A capsule is oral liquid, red, 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. The placebo supplement will have the same oil composition except that it will not contain vitamin A equivalent. Placebo oil and vitamin A preparation will be transferred to two colored (red and orange) Eppendorf® Safe-Lock microcentrifuge tubes volume 0.6 mL by a researcher who is not involved in the study.
Allocation
Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Iron&Vitamin A Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Vitamin A & Placebo Iron Supplements
Arm Type
Experimental
Arm Description
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)
Arm Title
Intermittent Iron Supplements & Placebo Vitamin A
Arm Type
Experimental
Arm Description
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).
Arm Title
Intermittent Iron Supplements & High dose Vitamin A
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Intermittent placebo iron supplement
Other Intervention Name(s)
Control iron
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Intermittent iron supplement
Other Intervention Name(s)
Experimental iron
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo Vitamin A
Other Intervention Name(s)
Control Vitamin A
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
High-dose Vitamin A supplement
Other Intervention Name(s)
Experimental Vitamin A
Intervention Description
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).
Primary Outcome Measure Information:
Title
Memory span
Description
Digit span (forward and backward) is a standardized test that assess the working memory of the children, one indicator of cognitive development
Time Frame
Memory span of the children will be assessed at 9 months
Title
Spatial exploration and awareness
Description
Vision search using cancellation task of the children, the second indicator of cognitive development
Time Frame
Spatial exploration and awareness of the children will be assessed at 9 months
Title
Reasoning ability
Description
Raven's colored progressive matrices, the third indicator of cognitive development
Time Frame
The reasoning ability of the children will be assessed at 9 months
Title
Anemia
Description
Hemoglobin concentrations (g/dL)
Time Frame
Hemoglobin concentrations of children will be assessed at 9 months
Title
Plasma ferritin
Description
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Time Frame
Plasma ferritin is assessed in all children at 9 months
Title
Soluble transferrin receptor
Description
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Time Frame
Soluble transferrin receptor is assessed in all children at 9 months
Secondary Outcome Measure Information:
Title
Serum concentrations in Vitamin A (retinol)
Description
Retinol concentrations in serum is an indicator of vitamin A status of children
Time Frame
Retinol concentrations will be assessed in all children at 9 months
Title
Serum concentrations in vitamin B12
Description
Serum concentrations in vitamin B12
Time Frame
Vitamin B12 concentrations will be assessed in all children at 9 months
Title
Prevalence of soil-transmitted helminths
Description
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).
Time Frame
The prevalence of soil-transmitted helminths will be assessed at 4.5 months and at 9 months
Title
Prevalence of Schistosome infection
Description
The prevalence of Schistosoma mansoni infection
Time Frame
Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months
Title
Adherence to the iron/placebo supplements
Description
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.
Time Frame
Weekly for the whole period of the intervention of 9 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefaan De Henauw, Md. PhD
Organizational Affiliation
University of Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arba Minch University
City
Arba Minch
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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).
Citations:
PubMed Identifier
24479203
Citation
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/
Results Reference
background
PubMed Identifier
22161444
Citation
De-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.
Results Reference
background
PubMed Identifier
9280190
Citation
Friis 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.
Results Reference
background
PubMed Identifier
16960172
Citation
Zimmermann 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.
Results Reference
background
PubMed Identifier
12080408
Citation
Mwaniki 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.
Results Reference
background

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Iron and Vitamin A in School Children

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