Protocol No: | ECCT/13/10/03 | Date of Protocol: | 02-02-2012 |
Study Title: | The Impact of Supplementation with Iron and Vitamin B12 Singly and In Combination on Nutritional Status and Morbidity Among Primary School Children. |
Study Objectives: | |
Laymans Summary: | |
Abstract of Study: | A randomized clinical controlled field trial in 360 randomly allocated primary school children aged 6 to 9 years with parental or guardian’s consent and attending selected schools in Kilifi District. The objective of the study is to determine the pre - and post - intervention impact of supplementation with iron and vitamin B12 singly and in combination on nutritional status, morbidity, haematological indices, serum ferritin, and serum vitamin B12 levels. Controls will be randomly allocated children receiving no intervention. Data collection will be by questionnaire on socio-demography, morbidity, 24 hour dietary recall, physical examination, anthropometric measurements, mid upper arm circumference, skin caliper thickness, class performance, total blood count; erythrocyte sedimentation rate, serum ferritin and vitamin B12 levels, This will be a repeat study design of above parameters at baseline, 3 months and six months. Collected information will be coded and cleaned. Exploratory Data Analysis will give descriptive statistics with frequencies, means, modes and median, quartile and inter-quartile ranges. Bivariate assessment will be done and categorical data subjected to Chi Square analysis and continuous data will be subjected to student t-test. Data with three or more variables will be subjected to ANOVA. Analysis will compare pre- and post- intervention variables between the study groups. |