Abstract
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. 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. 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. 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. 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.
Highlights
The period of transition from breastmilk to solid food is highly critical for the development of undernutrition in food-insecure populations
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 to support growth and nutritional status in Kenyan and Cambodian infants
Owino is affiliated with the Technical University of Kenya, Nairobi, Kenya; Jutta Skau, Roos Nanna, and Henrik Friis are affiliated with the University of Copenhagen, Denmark; Selina Omollo and Silvenus Konyole are affiliated with the University of Nairobi, Kenya; John Kinyuru is affiliated with the Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya; Benson Estambale is affiliated with Jaramogi Oginga Odinga University, Bondo, Kenya; Bethwel Owuor is affiliated with the Catholic University of East Africa, Nairobi, Kenya
Summary
The period of transition from breastmilk to solid food is highly critical for the development of undernutrition in food-insecure populations. Numerous studies [1,2,3] have reported mixed results on the effects of fortified cereal–legume blends on infant growth and micronutrient status. Few studies [4, 5] have assessed the benefits of animal-source foods to infant health in resource-poor settings. Edible insects and small fish species that are traditionally consumed in rural settings may be sources of high-quality protein and fatty acids that may enhance growth and micronutrient status during infancy. 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
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