dc.description.abstract | Background. Researchers face myriad challenges in the
design and implementation of randomized, controlled
trials. Apart from summaries on limitations, these challenges
are rarely documented in detail to inform future
research projects.
Objective. To describe methodological challenges
encountered during randomized, controlled trials (WinFood
Study) designed to assess the efficacy of locally
produced complementary foods based on traditional
animal-source foods (edible termites and spiders) to
support growth and nutritional status in Kenyan and
Cambodian infants.
Methods. In a randomized, controlled design, infants
received WinFood or corn–soy blend (CSB) for 9 months
from 6 to 15 months of age. Lean mass accrual and blood
nutrition indicators (lipid profile, iron and zinc status)
were measured cross-sectionally at 9 and 15 months of
age, respectively. Lean mass was determined by measuring
deuterium oxide enrichment in saliva samples following
a standard dose of deuterium solution (0.5 g/kg
body weight) to infants. Blood nutrition indicators were
determined following the drawing of 3 mL of blood by
venipuncture.
Results. Challenges included rapid depletion of food
rations, high rate of loss to follow-up, delayed ethical
approval, lack of local food-processing capacity,
low capacity among staff to draw blood, and lack of
laboratory capacity to perform both deuterium oxide
and micronutrient status measurements. Spillage of
deuterium oxide solution during dosing was a major
challenge in the Kenya context. A high rate of morbidity
among infants made some assessments very difficult,
especially drawing of blood and saliva samples.
Conclusions. The challenges were largely contextual.
Improvement of local laboratory capacity, training of
staff, and sensitization of the communities and the Ethics
Review Committee are highly recommended. | en_US |