Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

NCT ID: NCT03523182

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2018-01-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spirulina (SP)

Children in the SP group (n=251) received a soya-maize-based porridge for 12 months with the addition of spirulina.

Group Type: EXPERIMENTAL

Spirulina

Intervention Type: DIETARY_SUPPLEMENT

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.

Control

Intervention Type: DIETARY_SUPPLEMENT

Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.

Control (CON)

Children in the CON group (n=250) received a soya-maize-based porridge for 12 months.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Control

Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hitotsubashi University

OTHER

Sponsor Role: collaborator

Alliance Forum Foundation

UNKNOWN

Sponsor Role: collaborator

Programme Against Malnutrition

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazuya Masuda, PhD

Role: PRINCIPAL_INVESTIGATOR

Hitotsubashi University

Locations

Programme Against Malnutrition

Mansa, Luapura, Zambia

Countries

Zambia

Other Identifiers

FWA00000338

Identifier Type: -

Identifier Source: org_study_id