title: WinFood data from Kenya and Cambodia: constraints on field procedures.
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.
authors.forename: Victor O
authors.initials: VO
authors.lastname: Owino
authors.forename: Jutta
authors.initials: J
authors.lastname: Skau
authors.forename: Selina
authors.initials: S
authors.lastname: Omollo
authors.forename: Silvenus
authors.initials: S
authors.lastname: Konyole
authors.forename: John
authors.initials: J
authors.lastname: Kinyuru
authors.forename: Benson
authors.initials: B
authors.lastname: Estambale
authors.forename: Bethwel
authors.initials: B
authors.lastname: Owuor
authors.forename: Roos
authors.initials: R
authors.lastname: Nanna
authors.forename: Henrik
authors.initials: H
authors.lastname: Friis
mesh_terms: D000818:Animals; D001823:Body Composition; D002160:Cambodia; D003903:Deuterium; D017666:Deuterium Oxide / Q000032:analysis; D002523:Edible Grain; D005511:Food Handling; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007501:Iron / Q000097:blood; D020049:Isoptera; D007630:Kenya; D008055:Lipids / Q000097:blood; D009752:Nutritional Status; D012463:Saliva / Q000737:chemistry; D013112:Spiders; D015032:Zinc / Q000097:blood
chemical_list: D008055:Lipids; D003903:Deuterium; D007501:Iron; D015032:Zinc; D017666:Deuterium Oxide