Study on Preventing Anemia in Children in Ghana
Condition: Anaemia in Children
MeSH terms: Anemia
Study type: Interventional

Summary: 
      A study that seeks to establish an effective way of preventing anaemia in children at the
      community level using two known interventions - Iron supplementation and or antimalarial.
      Children recruited into the study will be assigned to four groups. Those receiving Placebo
      and Iron, those receiving Placebo and Antimalarial, those receiving Placebo and Antimalarial
      and those receiving double placebo. The children will be followed up over a period of nine
      months and their haemoglobin concentration, malaria parasites in their blood and their weight
      and height will be assessed.
    

Detailed description: 
      I. INTRODUCTION

      Anaemia in children is a major problem in developing countries 1. Iron deficiency is believed
      to be the most common form of anaemia in children. In some countries fortification of some
      common foods for children with iron has led to a decrease in morbidity and mortality
      associated with iron deficiency anemia.2 In malaria endemic areas, anaemia in children is
      made worse by incidence of malaria.

      Brief Background of the District

      Berekum District is one of the thirteen administrative districts in the Brong Ahafo Region of
      Ghana it has a total surface area of 1094.2 sq.km. The estimated population based on the 2000
      census with a growth rate of 2.5% is approximately 102,914 for the year 2004.Male to female
      ratio in the district is 1:1.1. The inhabitants are mainly Brongs with other ethnic groups
      from all over the country. 55.3% of the population live in the rural area.

      II. PROBLEM ANALYSIS

      Anaemia is recognised as a worldwide public health problem. It is estimated by the World
      Health Organization that the prevalence of anaemia defined by haemoglobin less than 11.0g/dl
      is about 33%.5 In Berekum District the prevalence of anaemia in children defined as
      haemoglobin concentration less than 10.0g/dl was found to be 80% in a nutritional survey
      carried out in communities in the district in 1994.6 Anaemia is one of the major causes of
      mortality in children under five years in Ghana.

      III. AIMS AND OBJECTIVES OF THE STUDY

      The aim of this study is to establish an effective way of preventing anaemia in children at
      the community level.

      The specific objectives of the study are:

        1. To determine the impact of weekly iron supplementation on the prevention of anaemia,
           increase in haemoglobin, growth parameters, and susceptibility to malaria (during and
           after treatment) in children 6-30months.

        2. To determine the impact of monthly sulphadoxine-pyrimethamine administration on the
           prevention of anaemia, increase in haemoglobin, growth parameters, and susceptibility to
           malaria (during and after treatment) in children 6-30months.

        3. To determine which of the interventions is more effective in preventing anaemia and
           increasing haemoglobin concentration in children aged 6-30months compared to placebo.

        4. To determine if there is a synergistic effect in giving both iron and
           sulphadoxine-pyrimethamine in preventing anaemia in children aged 6-30months.

        5. To find out the percentage of children who have adverse reaction when given
           Sulphadoxine-pyrimethamine.

        6. To determine if there is a difference in the incidence of clinical cases of vaccine
           preventable diseases among the intervention groups compared to the placebo.

      STUDY TYPE

      This is a Randomized double blind placebo-controlled study which will try to assess the
      effectiveness of three interventions in preventing anaemia in the community.

      STUDY POPULATION

      The universe population is all children 6months - 30months who reside in any of the
      communities in Berekum District. The target population are children who are 6months- 30months
      living in the Berekum District who attend well baby clinic.

      The study population will be the children who are between the ages 6months- 30months
      attending well baby clinic at twenty immunization sites in the district. Those who will
      attend child welfare clinic on the day the research team visit will be chosen if they fall
      within the age range and their mothers agree to let them take part in the study.

      SAMPLING

      Using 2x2 factorial design, a sample size of 189 per each of the four groups will be required
      to measure a difference in haemoglobin concentration between the groups within 0.5g/dl of the
      true value (alpha = 0.05). With an estimated drop out rate of 15% a total sample size of
      approximately 872 or 218 per group will be used.

      The placebo group represents the child welfare service that is currently available for
      children in the district, and in the rest of the country, so little ethical concerns are
      raised in recruiting children into the placebo group. They will also be of help in
      determining if there is difference in the occurrence of clinical cases of three vaccine
      preventable diseases(measles, acute flaccid paralysis and whooping cough) among children in
      any of the intervention groups compared to the placebo group, which can be used as a proxy
      indicator of possible adverse EPI vaccines and interventions interaction.

      An assumption is being made that since the district is very homogenous and consists mainly of
      one tribe predominantly, children selected at the various sites do not differ markedly from
      each other in terms of diet and exposure to other factors that might lead to anaemia.
      Furthermore, there is 98% child welfare attendance coverage in the District. Therefore,
      children attending child welfare clinics are quite representative of the community. Children
      at the twenty immunization/child welfare clinic sites in the district will randomly be
      assigned into one of the four study groups, after obtaining consent from their parents for
      them to be enrolled in the study. A simple randomization scheme will be utilized. Given the
      trial size, balance in treatment/placebo group sizes is anticipated. A recruitment
      questionnaire will be completed for all children recruited into the study.

      INTERVENTIONS

      The interventions that will be used are:

        1. Weekly iron supplementation Iron (II) Sulphate tablet at dose of 2mg/kg body weight and
           monthly placebo resembling sulphadoxine-pyrimethamine tablet.

        2. Weekly placebo resembling Iron (II) Sulphate tablet and monthly treatment with
           sulphadoxine-pyrimethamine according to body weight (¼ tablet for those < 5kg, ½ tablet
           for those 5-10 kg and 1 tablet for those 10-15kg.

        3. Weekly iron supplementation Iron (II) Sulphate tablet at dose of 2mg/kg body weight and
           monthly Sulphadoxine-pyrimethamine tablet

        4. Weekly placebo resembling iron (II) sulphate tablet and monthly placebo resembling
           sulphadoxine-pyrimethamine tablet

      Interventions will be pre-packed and labelled with drug code numbers by the manufacturers.
      Children will randomly be assigned to a pre-packed drug by community health nurses working in
      the community. Community health nurses will not be aware of which intervention each child is
      receiving. Code as to what each child is on will be held in a seal and kept by the drug
      manufacturers, till data is ready for analysis. To ensure compliance, every week community
      health nurses will visit the communities and give the drugs to the children under direct
      observation.

      FOLLOW-UP

      The intervention will be given to the children for a period of 6months.Children will be
      followed up for another 3months post-intervention. Community Health Nurses will visit
      children weekly to assess cutaneous reactions and check axillary temperature. At baseline,
      2months, 4months, 6months and 9months blood samples will be taken to measure haemoglobin
      concentration in g/dl to assess anaemia. Haemoglobin concentration will be measured twice for
      each child on each occasion. Malaria will be determined by looking at thick and thin blood
      film, which will be stained and read using standard procedure to look for asexual forms of P
      falciparum4. Children seen in the community by the community health nurses with axillary
      temperature above 37.5 Celsius without any complications will be treated with Chloroquine
      according to their weight; those with complicated malaria will be admitted to the ward. The
      project will pay for this treatment. Haemoglobin electrophoresis for sickle cell will be done
      using cellulose acetate. The weight and length of the children will be taken at baseline,
      2months, 4months, 6months and 9months by the four community health nurses working at
      immunization sites.

      V. PLAN FOR DATA ANALYSIS

      Data will be analyzed using Epi 2000.Difference in Haemoglobin change between the groups over
      the period will be determined using the Student t-test at 95% confidence interval. Proportion
      of those with weight to age and length to age ratio between -2SD and +2SD and those with
      Plasmodium falciparum in thick peripheral blood film will be calculated. These two
      proportions will be compared between the two interventions and the placebo at the various
      time periods using Chi-square analysis; it will be determined where there is significance
      difference between the proportions of the interventions at 95% confidence interval compared
      to each other and compared to the placebo group. Average febrile episodes will be compared
      between the interventions and the placebo using ANOVA to determine significance difference at
      95% confidence interval.

      VI. ETHICAL ISSUES

      Proposal for study will be submitted to the National committee for ethics in Research.
      Interventions that will be used have a long history of use and most of the side-effects are
      already known and have been documented. Giving Iron supplementation to children is a public
      health intervention that has been done in a lot of settings to prevent anaemia and found to
      be safe. Use of sulphadoxine-pyrimethamine in treating malaria is also very extensive
      especially in the Southern parts of Africa. Children will be closely monitored, and mothers
      will be required to report any adverse reactions that they notice. Children who appear to
      react adversely to any of the interventions will be dropped from the study. . Mothers' access
      to routine health services for their children will not be affected by mother's refusal to
      participate in this study.

      Verbal informed consent will be obtained from mothers of chosen children.
    

Intervention name(s): Ferrous sulphate; Sulphadoxine-Pyrimethamine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Anaemia; Malaria; Rural Area in Ghana