Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

Malaria Clinical Trial

Official title:

Promoting Spirulina Production and Utilization in Luapula Province of Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523182
• Other study ID #: FWA00000338
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: January 30, 2018

Study information

• Verified date: February 2019
• Source: Programme Against Malnutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: January 30, 2018
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Fever
• Malaria
• Motor Delay
• Pneumonia
• Pneumonia, Pneumocystis
• Stunting
• Thinness
• Underweight

Intervention

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

Locations

Country	Name	City	State
Zambia	Programme Against Malnutrition	Mansa	Luapura

Sponsors (3)

Lead Sponsor	Collaborator
Programme Against Malnutrition	Alliance Forum Foundation, Hitotsubashi University

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change from baseline in weight-for-age z-scores (WAZ) at 32 month follow up	Secondary outcome is changes in WAZ. Weight of the infants is transformed to standardized scores using the WHO Multicentre Growth Standards	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)
Secondary	Change from baseline in pneumonia incidence at 32 month follow up	Secondary outcome is changes in pneumonia incidence. Pneumonia was defined as cough accompanied by short and rapid breathing and difficulty in breathing	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)
Secondary	Change from baseline in cough incidence at 32 month follow up	Secondary outcome is changes in cough incidence in the 4 weeks preceding the interview.	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)
Secondary	Change from baseline in severe high fever incidence at 32 month follow up	Secondary outcome is changes in severe high fever incidence. Severe high fever was defined based on the following clinical signs: fever with rash on child's body, fever with chills, shaking, nausea, or alternating high and low body temperature	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)
Secondary	Change from baseline in fever incidence at 32 month follow up	Secondary outcome is changes in fever incidence in the 4 weeks preceding the interview	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)
Secondary	Ability of the infant to walk independently.	The ability of children to walk without assistance measured by the questionnaire.	This indicator was evaluated at 0, 6 and 12 months by research assistants who visited the participants' homes
Secondary	Child development at 24 month follow up	Study children will be assessed at 24 month follow up (April 2017) 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 24 month follow up survey (April 2017)