Effects of spirulina supplement on children's growth and health

Evaluation of daily spirulina as a nutritional supplement in school children: a placebo-controlled randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11696165

Enrollment

215

Registered

2018-12-12

Start date

2014-12-01

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Young children from an impoverished setting in Cambodia attending preschools Nutritional, Metabolic, Endocrine

Interventions

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 partici

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 f

sex ratio F/M: 0.83) attending preschool cared by “Pour un sourire d’enfants” (PSE) a charity-supported training school, were randomly and double-blindly allocated (2 to 1) to SP (Group 1) or placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Known allergy to SP before the survey 2. Inability to attend school during the subsequent 8 months

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Cambodia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026