Clinical trial NCT03523182: Spirulina Supplementation and Infant Growth, Morbidity and Motor Development
Official title: Promoting Spirulina Production and Utilization in Luapula Province of Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stunting
Underweight
Pneumonia, Pneumocystis
Cough
Malaria
Fever
Motor Delay
Keywords: Micronutrient supplementation
Home fortification
Spirulina
Zambia
Lead sponsor: Programme Against Malnutrition
Sponsor class: OTHER
Collaborators: name: Hitotsubashi University
name: Alliance Forum Foundation
First posted: 2018-05-14
Enrollment: 501
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All infants were eligible for the study if they are between 6 and 18 month of age

Exclusion Criteria:

* Non-singleton birth infants were excluded

Primary outcomes:
measure: Change from baseline in height-for-age z-scores (HAZ) at 32 month follow up
timeFrame: Height of the infants are measured by experienced field workers at at 0, 6, and 12 month. Amendment: also measured at extension endline (October 2016), at 24 month follow up (April 2017) and at 32 month follow up (January 2018) survey.
measure: Child development
timeFrame: At 32 month follow up (January 2018) survey
Secondary outcomes:
measure: Change from baseline in weight-for-age z-scores (WAZ) at 32 month follow up
timeFrame: Weight of the infants are measured at 0, 6, and 12 month by experienced field workers. Amendment: also measured at extension endline (October 2016), at 24 month follow up (April 2017) and at 32 month follow up (January 2018)
measure: Change from baseline in pneumonia incidence at 32 month follow up
timeFrame: Data on pneumonia indicators were collected up to 12 months by trained local health workers. Amendment: also measured at extension endline (October 2016), at 24 month follow up (April 2017) and at 32 month follow up (January 2018)
measure: Change from baseline in cough incidence at 32 month follow up
timeFrame: Data on cough morbidity indicators are collected up to 12 months by trained local health workers. Amendment: also measured at extension endline (October 2016), at 24 month follow up (April 2017) and at 32 month follow up (January 2018)
measure: Change from baseline in severe high fever incidence at 32 month follow up
timeFrame: Data are collected up to 12 months by trained local health workers. Amendment: also measured at extension endline (October 2016), at 24 month follow up (April 2017) and at 32 month follow up (January 2018)
measure: Change from baseline in fever incidence at 32 month follow up
timeFrame: Data are collected up to 12 months by trained local health workers. Amendment: also measured at extension endline (October 2016), at 24 month follow up (April 2017) and at 32 month follow up (January 2018)
measure: Ability of the infant to walk independently.
timeFrame: This indicator was evaluated at 0, 6 and 12 months by research assistants who visited the participants' homes
measure: Child development at 24 month follow up
timeFrame: At 24 month follow up survey (April 2017)
Other outcomes:
Locations:
city: Mansa
country: Zambia
facility: Programme Against Malnutrition
state: Luapura
Study officials:
affiliation: Hitotsubashi University
name: Kazuya Masuda, PhD
role: PRINCIPAL_INVESTIGATOR
References: