Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00301054 |
| Other study ID # |
2003/GD/23 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 9, 2006 |
| Last updated |
May 26, 2006 |
| Start date |
June 2005 |
| Est. completion date |
April 2006 |
Study information
| Verified date |
July 2005 |
| Source |
Ghana Health Services |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Ghana: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial 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.
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.
