TY - JOUR

T1 - WinFood data from Kenya and Cambodia

T2 - constraints on field procedures

AU - Owino, Victor O

AU - Skau, Jutta Kloppenborg Heick

AU - Omollo, Selina

AU - Konyole, Silvenus

AU - Kinyuru, John

AU - Estambale, Benson

AU - Owuor, Bethwel

AU - Roos, Nanna

AU - Friis, Henrik

AU - WinFood Project Team

N1 - CURIS 2015 NEXS 147

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

U2 - 10.1177/15648265150361S107

DO - 10.1177/15648265150361S107

M3 - Journal article

C2 - 25902613

VL - 36

SP - S41-S46

JO - Food and Nutrition Bulletin

JF - Food and Nutrition Bulletin

SN - 0379-5721

IS - Suppl. 1

ER -