Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

NCT03523182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2019-02-11

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03523182 on ClinicalTrials.gov