Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Iron and Vitamin A in School Children (IronVitA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137354
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborators:
Flemish Interuniversity Council (VLIR)
Arba Minch University, Ethiopia
Information provided by (Responsible Party):
VakgroepVolksgezondheidEnEerstelijnszorg, University Ghent

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.


Condition or disease Intervention/treatment Phase
Anemia, Iron Deficiency Vitamin A Deficiency Cognitive Development Helminthic Infection Other: Intermittent placebo iron supplement Other: Intermittent iron supplement Other: Placebo Vitamin A Other: High-dose Vitamin A supplement Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose: Prevention
Official Title: Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Placebo Comparator: Control Iron&Vitamin A Placebo
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).
Other: Intermittent placebo iron supplement
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)
Other Name: Control iron

Other: Placebo 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).
Other Name: Control Vitamin A

Experimental: Vitamin A & Placebo Iron Supplements
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)
Other: Intermittent placebo iron supplement
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)
Other Name: Control iron

Other: High-dose Vitamin A supplement
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).
Other Name: Experimental Vitamin A

Experimental: Intermittent Iron Supplements & Placebo Vitamin A

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).

Other: Intermittent iron supplement
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)
Other Name: Experimental iron

Other: Placebo 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).
Other Name: Control Vitamin A

Experimental: Intermittent Iron Supplements & High dose Vitamin A
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).
Other: Intermittent iron supplement
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)
Other Name: Experimental iron

Other: High-dose Vitamin A supplement
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).
Other Name: Experimental Vitamin A




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Anemia [ Time Frame: Hemoglobin concentrations of children will be assessed at 9 months ]
    Hemoglobin concentrations (g/dL)

  5. 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

  6. 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


Secondary Outcome Measures :
  1. Serum concentrations in Vitamin A (retinol) [ Time Frame: Retinol concentrations will be assessed in all children at 9 months ]
    Retinol concentrations in serum is an indicator of vitamin A status of children

  2. Serum concentrations in vitamin B12 [ Time Frame: Vitamin B12 concentrations will be assessed in all children at 9 months ]
    Serum concentrations in vitamin B12

  3. Prevalence of soil-transmitted helminths [ Time Frame: The prevalence of soil-transmitted helminths will be assessed at 4.5 months and at 9 months ]
    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).

  4. Prevalence of Schistosome infection [ Time Frame: Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months ]
    The prevalence of Schistosoma mansoni infection

  5. Adherence to the iron/placebo supplements [ Time Frame: Weekly for the whole period of the intervention of 9 months. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137354


Contacts
Layout table for location contacts
Contact: Souheila Abbeddou, PhD 00329 3322423 Souheila.Abbeddou@UGent.be
Contact: Befikadu Tariku Gutema, MSc. 00251912361811 befikadutariku.gutema@ugent.be

Locations
Layout table for location information
Ethiopia
Arba Minch University Recruiting
Arba Minch, Ethiopia
Contact: Befikadu Tariku Gutema, MSc.    00251912361811    befikadutariku.gutema@ugent.be   
Contact: Eshetu Zerihun, MSc.    00251917835302    eshetamu@gmail.com   
Sponsors and Collaborators
University Ghent
Flemish Interuniversity Council (VLIR)
Arba Minch University, Ethiopia
Investigators
Layout table for investigator information
Principal Investigator: Stefaan De Henauw, Md. PhD University of Ghent
Publications:
Layout table for additonal information
Responsible Party: VakgroepVolksgezondheidEnEerstelijnszorg, Prof. Dr. Stefaan De Henauw, University Ghent
ClinicalTrials.gov Identifier: NCT04137354    
Other Study ID Numbers: EC/2019/1289
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VakgroepVolksgezondheidEnEerstelijnszorg, University Ghent:
Intermittent Iron supplementation
Vitamin A
Cognitive Development
Anemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Helminthiasis
Night Blindness
Anemia, Iron-Deficiency
Vitamin A Deficiency
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Parasitic Diseases
Vitamins
Vitamin A
Iron
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents