NCT03523182

Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

Promoting Spirulina Production and Utilization in Luapula Province of Zambia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Programme Against Malnutrition · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

Summary

Background: In developing countries, micronutrient deficiency in infants is associated with growth faltering, morbidity, and delayed motor development. One of the potentially low-cost and sustainable solutions is to use locally producible food for the home fortification of complementary foods. Objective: The objectives are to test the hypothesis that locally producible spirulina platensis supplementation would achieve the following: 1) increase infant physical growth; 2) reduce morbidity; and 3) improve motor development. Design: 501 Zambian infants are randomly assigned into a control (CON) group or a spirulina (SP) group. Children in the CON group (n=250) receive a soya-maize-based porridge for 12 months, whereas those in the SP group (n=251) receive the same food but with the addition of spirulina. The change in infants' anthropometric status, morbidity, and motor development over 12 months are assessed.

Detailed description

Micronutrient deficiency in the infancy is associated with growth faltering, morbidity, and delayed motor development, and is common in developing countries where the food available for infants has low micronutrient density. A low-cost and sustainable way to address this problem is to utilize locally producible foods rich in multi-micronutrients as home supplements to complementary food. Arthrospira platensis, also known as spirulina, is a blue-green micro-algae indigenous to Africa. It contains a high percentage of protein, and is rich in multiple micronutrients know to support infant growth such as beta carotene, B vitamins, and minerals such as calcium, iron, magnesium, manganese, potassium, and zinc. The cost of producing spirulina is much lower than that of producing other comparably protein-rich foods, such as soya beans and beef, and therefore may potentially sustainably meet the nutritional demands of African infants. Our objective is to assess the acceptability and effects of spirulina supplementation on growth, incidence of morbidity, and level of motor development in infants in Zambia. The testable hypothesis is that spirulina supplementation for 12 months would increase infant height, reduce the incidence of morbidity, and reduce time taken to achieve motor development milestones (ability to walk unassisted). This study is conducted from April 2015 to April 2016 in the form of an open-labeled randomized control trial, and involves in a spirulina-fed treatment (SP) group and a control (CON) group. 501 Zambian infants are randomly assigned into a control (CON) group or a spirulina (SP) group. Children in the CON group (n=250) receive a soya-maize-based porridge for 12 months, whereas those in the SP group (n=251) receive the same food but with the addition of spirulina. The change in infants' anthropometric status, morbidity, and motor development over 12 months are assessed. Amendment: the study period has been extended by 4 months. Without no-intervention period, monthly supplementation was restarted in study are.

Conditions

• Stunting
• Underweight
• Pneumonia, Pneumocystis
• Cough
• Malaria
• Fever
• Motor Delay

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Spirulina	Arthrospira platensis, also known as spirulina, is a blue-green micro-algae indigenous to Africa. Spirulina group (n=251) receive a soya-maize-based porridge with the addition of spirulina. We used 10 g per day of spirulina powder with a mealie meal and soya flour porridge blend.
DIETARY_SUPPLEMENT	Control	Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-04-30
• Completion: 2018-01-30
• First posted: 2018-05-14
• Last updated: 2019-02-11

Locations

1 site across 1 country: Zambia