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Completed

NCT Number: NCT03523182

Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

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.

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Key information

Conditions

Stunting Bacterial Infections and Mycoses Body Temperature Changes Body Weight Cough Fever Growth Disorders Infections Lung Diseases Lung Diseases, Fungal Malaria Mosquito-Borne Diseases Motor Delay Mycoses Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis Protozoan Infections Psychomotor Disorders Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Thinness Underweight Vector Borne Diseases

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Programme Against Malnutrition

Mansa, Luapura, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Dietary Supplement

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

Primary outcomes

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

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

  2. Child development

    Time frame: At 32 month follow up (January 2018) survey

    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.

Secondary outcomes

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

    Time frame: 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 outcome is changes in WAZ. Weight of the infants is transformed to standardized scores using the WHO Multicentre Growth Standards

  2. Change from baseline in pneumonia incidence at 32 month follow up

    Time frame: 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 outcome is changes in pneumonia incidence. Pneumonia was defined as cough accompanied by short and rapid breathing and difficulty in breathing

  3. Change from baseline in cough incidence at 32 month follow up

    Time frame: 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 outcome is changes in cough incidence in the 4 weeks preceding the interview.

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

    Time frame: 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 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

  5. Change from baseline in fever incidence at 32 month follow up

    Time frame: 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 outcome is changes in fever incidence in the 4 weeks preceding the interview

  6. Ability of the infant to walk independently.

    Time frame: This indicator was evaluated at 0, 6 and 12 months by research assistants who visited the participants' homes

    The ability of children to walk without assistance measured by the questionnaire.

  7. Child development at 24 month follow up

    Time frame: At 24 month follow up survey (April 2017)

    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.

Sponsors and collaborators

Lead sponsor

Programme Against Malnutrition

Other

Collaborators

  • Alliance Forum Foundation
  • Hitotsubashi University

Registry information

Official study title

Promoting Spirulina Production and Utilization in Luapula Province of Zambia

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
May 14, 2018
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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