Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01878734 |
| Other study ID # |
H13-00261 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 5, 2013 |
| Last updated |
June 2, 2015 |
| Start date |
June 2013 |
| Est. completion date |
November 2014 |
Study information
| Verified date |
June 2015 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Zambia: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial Summary
Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the
government due to its major contribution to morbidity and mortality among children,
especially infants in their formative years. One of the most successful, cost-effective, and
recommended strategy to address micronutrient malnutrition is 'in-home fortification' with
micronutrient powders (Sprinkles being the most widely recognized) along with nutrition
education. While this intervention has proven to be safe, effective, and efficacious in
numerous other countries, a specific national protocol must be developed to maximize its
effect on reducing anaemia in Zambian children. The proposed research aims to inform such
protocol.
Description:
1. Purpose While Zambia has made progress towards reducing under-nutrition among children,
as measured by underweight, other indicators of nutritional status, particularly
stunting and anaemia have remained unchanged over the past decades. Repeated national
surveys show that anaemia remains of public health significance among Zambian children.
According to WHO classification, a prevalence of anaemia above 40% is categorized as a
severe public health problem. There has been no significant reduction in anaemia among
children 6-59 months over the past two decades with an estimated prevalence of 60% in
1998, 53% in 20032 and 49% in 20093. Further, younger infants were found to be more
affected than older children with an estimated prevalence of 81% in children 6-18
months in 1992 and 61% in children 6-24 months in 2009. In developing countries
approximately 50% of all anaemia is attributed to iron deficiency. It is further
estimated that the frequency of iron deficiency is about 2.5 times that of anaemia, and
when anaemia prevalence exceeds 40%, it is assumed that the entire population is
suffering from some degree of iron deficiency. It is therefore assumed that this is the
case with young children in Zambia. It is well established that iron deficiency has
adverse health consequences even before anaemia develops. These include cognitive
impairment, decreased physical capacity and reduced immunity.
The most promising strategy for this age group is 'home fortification' of staple
complementary foods (foods that are consumed in addition to breast milk after 6 months
of age) with small packets of Micronutrient Powders (MNP) that can be easily mixed with
home-prepared food.
MNP are packed in single-serve sachets of mixed vitamins and minerals in powder form,
which can be instantly sprinkled on prepared ready-to-eat complementary foods for young
children without changing the colour or taste of the food. The sachets are packed to
ensure that the correct amounts of micronutrients are given.
As 'stunting', low height for age, is a problem of public health significance in Zambia
with 45% of children under five being stunted, this programme will specifically address
practices that will help to improve nutritional intake and reduce infection in order to
promote growth during the early years of life.
Therefore the purpose of this project will be to conduct a 12 month trial of MNP in the
Northern Province of Zambia, in order to inform a future scale up.
2. Justification Home fortification with MNP has proved to be efficacious and effective in
reducing the prevalence of iron deficiency anaemia in young children. Today, MNP are
successfully used in 45-50 countries worldwide. Based on the large body of evidence
available, the WHO strongly recommends the use of MNP containing at least iron, vitamin
A and zinc to improve iron status and reduce anaemia in children 6-23 months of age
where the prevalence of anaemia in children under two years or under five years of age
is 20% or higher.
Previous trials have shown a reduction in anaemia by 31%, iron deficiency by 51% in
young children consuming MNP and by 20-30% in a few programmatic settings. Furthermore,
MNP have been shown to be as effective in treating and preventing anaemia as iron
syrup. In 2011, studies in both Nepal and Kenya reported a significant decrease in the
prevalence of stunting following the inclusion of MNP in programmes for children 6-59
months of age.
While studies have demonstrated MNP to be efficacious and effective in specific
settings, it is recognized that the findings from one country are not transferable to
another due to differences in acceptability in accordance with cultural practices,
economics, food availability and particularly infant and child feeding practices. This
project was designed to fill the need for a country specific programme with regionally
relevant training materials, packaging, messages for mothers and distribution system.
Through our previous work we developed communications materials and packaging for MNP
in Zambia following a feasibility study and 30-day trial. We evaluated acceptability,
utilization and compliance of MNP and have modified training materials based on our
findings. We are now prepared to conduct a 12-month pilot study on MNP integrated with
IYCF in two districts as the basis for developing an evidence-based policy for
implementing MNP at scale in Zambia.
3. Objectives of the MNP Pilot
- To demonstrate effectiveness of MNP in reducing iron deficiency and anaemia in
children 6-23 months after 12 months of supplementation;
- To evaluate the effectiveness of an integrated MNP and IYCF package in improving
child nutritional status and growth;
- To quantify the impact of an integrated MNP and IYCF package on reducing iron
deficiency and anaemia and improving the nutritional status of children.
- To develop a MNP communication strategy and Behaviour Change Communication
materials.
- To develop a national plan and policy recommendations for the scale-up and
integration of MNP into IYCF.
4. Research Method The 'Home Fortification Programme with MNP for Young Children in
Zambia' has been designed as a multiphase project with the first phase consisted of two
components, a feasibility study and a 30-day trial of MNP. The findings of the
previously conducted feasibility study and the 30-day trial have been integrated into
the design of the pilot phase, which will inform how best to scale up the MNP
intervention in Zambia.
Methods have been developed in accordance with the overall pilot programme goals and
objectives, taking into consideration the limitations of implementing a rigorous scientific
design in resource poor settings where access, transportation and communication, are
limited. Ethical considerations do not allow for a control group as the prevalence of
anaemia is presumed to be high and the efficacy of MNP at reducing anaemia, established.
The pilot will be conducted in rural communities of Mbala district in the Northern Province.
The population for the government's MNP and IYCF intervention is all children 6-23 months
and their caregivers, living in Mbala district, Northern Province. It is estimated that due
to logistical constraints, of 26 health facilities, only 9 will be involved in the pilot.
Therefore the target population will be approximately 2,350 children.
The formulation for the MNP used in the pilot will contain 15 micronutrients including iron,
zinc, vitamin A, C, D, B group vitamins, folic acid and iodine in order to control other
micronutrient deficiencies commonly found in the same individuals. The formulation takes
into account the recommended daily micronutrient requirements for children 6-23 months, the
availability from other sources including on-going nutrition programmes and the upper level
of individual micronutrients. The MNP formula can be safely provided to children that
receive bi-annual high dose vitamin A, or consume iodized salt.
Caregivers of children 6-23 months will be supplied with boxes of 30 sachets every two
months over the duration of one year. This will cover 50% of the recommended Nutrient Intake
for iron for a child in this age group. The MNP will be delivered to selected families
through the primary health care system.
An effectiveness study has been embedded within the pilot programme to assess the effect of
the MNP plus IYCF intervention package in relation to the programme's goals and outcomes
under programmatic conditions within the target population. There will be two distinct
groups invited to participate in the effectiveness component of the pilot, both in the
district of Mbala. One will serve as a control group, and as such will not receive MNP. Both
the treatment group and control groups will receive IYCF and early child development (ECD)
training, deworming tablets (Mebendazole) and insecticide-treated nets, while the treatment
group will additionally receive MNP.
Mother-child pairs from the two groups will be closely followed across the 12 month
intervention period with an in-depth assessment taking place at three points in time;
baseline, 6 months and 12 months after the intervention begins. The baseline evaluation will
be conducted before the mothers are trained in the use of MNP as part of complementary
feeding. The tools used for the assessment are described below.
The primary outcome variable used for the determination of the sample size for the
effectiveness component of the study is a change in prevalence of anaemia among
participating children (defined as haemoglobin < 11.0 g/dL) over the course of the 12-month
intervention in the district of Mbala
Data collected will include anthropometry, in the form of MUAC, wasting (Weight-for-height),
stunting (height-for-age), and weight-for-age. Biochemical data will be haemoglobin, serum
ferritin, and serum transferrin receptor to measure iron status, C-reactive protein and
alpha-1 acid glycoprotein will be used to control for infections, and retinol binding
protein to measure vitamin A status. There will also be questionnaires, consisting of
quantitative and qualitative questions, that will be administered.
6) Statistical Analysis
Data will be entered in the field into Excel and later transferred to an SPSS file for
analysis. At baseline, descriptive characteristics will be calculated for all variables and
key outcome variables compared across groups. At midline and end-line comparisons will be
made across time among the three groups using means, standard deviation, and proportions as
relevant. The p-value will be set at 0.05 with adjustments made for multiple comparisons.
