Spirulina Supplementation and Infant Growth, Morbidity and Motor Development
NCT03523182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501
Last updated 2019-02-11
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Hitotsubashi University
collaborator OTHER -
Alliance Forum Foundation
collaborator UNKNOWN -
Programme Against Malnutrition
lead OTHER
Principal Investigators
-
Kazuya Masuda, PhD · Hitotsubashi University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 18 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-03-01
- Primary Completion
- 2016-04-30
- Completion
- 2018-01-30
Countries
- Zambia
Study Locations
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