An interventional study of Spirulina and Control in Stunting, Underweight and Pneumonia, Pneumocystis, sponsored by Programme Against Malnutrition. Completed at 1 site in Zambia. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Programme Against Malnutrition · Not applicable, Interventional, and Treatment
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.
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.
227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.
This study's enrollment of 501 is above the median of 413 across 143 interventional studies indexed under Growth Disorders.
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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
Children in the CON group (n=250) received a soya-maize-based porridge for 12 months.
Dietary Supplement: Control
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.
Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.
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
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.
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.
Time frame: At 32 month follow up (January 2018) survey
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
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)
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
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)
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.
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)
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
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)
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
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)
Ability of the infant to walk independently.
The ability of children to walk without assistance measured by the questionnaire.
Time frame: This indicator was evaluated at 0, 6 and 12 months by research assistants who visited the participants' homes
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.
Time frame: At 24 month follow up survey (April 2017)
Plan to share: No
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Ran from Mar 2015 to primary completion in Apr 2016, 13 months.
Of 77 non-industry interventional studies with no phase under Growth Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 30. This study's 13 months is below that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 12 and three quarters within 30.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spirulina maxima