Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

NCT03523182 | Completed

• 1 other identifier: FWA00000338
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Micronutrient supplementation; Home fortification; Spirulina; Zambia

Outcome Measures

Primary Outcomes (2)

• Change from baseline in height-for-age z-scores (HAZ) at 32 month follow up

  Primary outcome is changes in HAZ. Height of the infants is transformed to standardized scores using the World Health Organization (WHO) Multicentre Growth Standards

  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.

• Child development

  Study children will be assessed at 32 month follow up (January 2018) using the Malawi Development Assessment Tool (MDAT) instrument. Scores will be standardized within the study sample for analysis. Scores of children in treatment group will be compared with children in comparison group to determine differences.

  At 32 month follow up (January 2018) survey

Secondary Outcomes (7)

• Change from baseline in weight-for-age z-scores (WAZ) at 32 month follow up

  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)

• Change from baseline in pneumonia incidence at 32 month follow up

  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)

• Change from baseline in cough incidence at 32 month follow up

  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)

• Change from baseline in severe high fever incidence at 32 month follow up

  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)

• Change from baseline in fever incidence at 32 month follow up

  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)

Study Arms (2)

Spirulina (SP)

EXPERIMENTAL

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

Dietary Supplement: Spirulina; Dietary Supplement: Control

Control (CON)

ACTIVE COMPARATOR

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

Dietary Supplement: Control

Interventions

Spirulina 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.

Spirulina (SP)

Control DIETARY_SUPPLEMENT

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

Control (CON); Spirulina (SP)

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Non-singleton birth infants were excluded

Sponsors & Collaborators

• Programme Against Malnutrition: lead
• Hitotsubashi University: collaborator
• Alliance Forum Foundation: collaborator

Study Sites (1)

Programme Against Malnutrition

Mansa, Luapura, Zambia

Location

MeSH Terms

Conditions

Growth Disorders; Thinness; Pneumonia, Pneumocystis; Cough; Malaria; Fever; Psychomotor Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight; Signs and Symptoms; Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Kazuya Masuda, PhD

  Hitotsubashi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 14, 2018
• Study Start: March 1, 2015
• Primary Completion: April 30, 2016
• Study Completion: January 30, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)