Anemia, Iron Deficiency Clinical Trial
— IronVitAOfficial title:
Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.
Verified date | March 2023 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 504 |
Est. completion date | December 28, 2021 |
Est. primary completion date | December 28, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Arba Minch University | Arba Minch |
Lead Sponsor | Collaborator |
---|---|
University Ghent | Arba Minch University, Ethiopia, Flemish Interuniversity Council (VLIR) |
Ethiopia,
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. — View 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. — View 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/ — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Memory span | Digit span (forward and backward) is a standardized test that assess the working memory of the children, one indicator of cognitive development | Memory span of the children will be assessed at 9 months | |
Primary | Spatial exploration and awareness | Vision search using cancellation task of the children, the second indicator of cognitive development | Spatial exploration and awareness of the children will be assessed at 9 months | |
Primary | Reasoning ability | Raven's colored progressive matrices, the third indicator of cognitive development | The reasoning ability of the children will be assessed at 9 months | |
Primary | Anemia | Hemoglobin concentrations (g/dL) | Hemoglobin concentrations of children will be assessed at 9 months | |
Primary | Plasma ferritin | Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores | Plasma ferritin is assessed in all children at 9 months | |
Primary | Soluble transferrin receptor | Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings | Soluble transferrin receptor is assessed in all children at 9 months | |
Secondary | Serum concentrations in Vitamin A (retinol) | Retinol concentrations in serum is an indicator of vitamin A status of children | Retinol concentrations will be assessed in all children at 9 months | |
Secondary | Serum concentrations in vitamin B12 | Serum concentrations in vitamin B12 | Vitamin B12 concentrations will be assessed in all children at 9 months | |
Secondary | 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). | The prevalence of soil-transmitted helminths will be assessed at 4.5 months and at 9 months | |
Secondary | Prevalence of Schistosome infection | The prevalence of Schistosoma mansoni infection | Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months | |
Secondary | 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. | Weekly for the whole period of the intervention of 9 months. |
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