Effects of spirulina supplement on children's growth and health

INTERVENTION: All parents/guardians/caregivers were informed by the school manager and were provided an information file in Khmer. Children of those who provided oral consent to the study were enrolled. The participant information file and informed consent sheet provided the following details: the exact nature of the survey; what it would involve for the participant; the implications and constraints of the protocol; the known side‐effects and risks involved in taking part in the study. It was clearly stated that the participant was free to withdraw from the survey at any time for any reason without prejudice to future care at PSE health services or PSE education and with no obligation to give the reason for withdrawal. An information session in Khmer was conducted at PSE with PSE teachers and staff prior to enrolment to ensure that the parents understood the survey design, objectives and the study activities and that they understood the monitoring and blindness. They were given the opportunity to ask questions and receive answers. Teachers were able to provide additional information to parents/guardians/caregivers. In case of side effects or disease, children were to be sent to the nursery and, if appropriate, to the PSE doctor. The supplementation was either to be discontinued or decreased and treatment to be provided according to PSE and Cambodian National health guidelines. The protocol, informed consent form, and participant information sheet were submitted to and received agreement from the Cambodian Research Ethics Committee. Children (4.9 years, 95%CI: 4.7–5.1; sex ratio F/M: 0.83) attending preschool cared by “Pour un sourire d’enfantsâ€? (PSE) a charity‐supported training school, were randomly and double‐blindly allocated (2 to 1) to SP (Group 1) or placebo (Group 0) 2 g daily for 8 weeks (Phase 1). After 8 weeks of wash‐out period, participants were crossed over to the other group (Phase CONDITION: Young children from an impoverished setting in Cambodia attending preschools ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: 1. Change in nutritional status assessed using anthropometric measurements (weight, height, body mass index [BMI]) calculated using UNICEF tools assessed prior to the survey, then 2 months after the first and the second supplementation phases INCLUSION CRITERIA: 1. Children aged 5 to 6 years 2. Attending preschool 3. Informed oral consent of their parents/guardians 4. Following a medical screening at PSE health center SECONDARY OUTCOME: ; 1. Tolerability of supplements was directly observed by teachers. Events such as nausea, vomiting, allergic reaction, headache, and fever or other symptoms were recorded daily on a standardized pre‐tested one sheet form by the teachers . Standard pre‐tested sheets were prepared to make it easy for teachers to record daily any symptomatic health events, compliance or reactions to supplements. Data sheets were monitored daily during the first 2 weeks by a survey assistant, then twice weekly.; 2. Occurrence of illness was recorded using the data sheets daily during the first 2 weeks by a survey assistant, then twice weekly. The occurrence of health events or diseases was systematically sought from teachers at each visit in the event of children dropping out.; 3. Haematological data, including hemoglobin, blood cell count, C‐reactive protein and ferritin, assessed before intervention and at the end of each treatment period;