Malaria Clinical Trial
Official title:
Promoting Spirulina Production and Utilization in Luapula Province of Zambia
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.
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.
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