StuntingNCT03523182
Spirulina Supplementation and Infant Growth, Morbidity and Motor Development
A study testing Spirulina in people with Stunting and Underweight, run by Programme Against Malnutrition at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting, Underweight, Pneumonia, Pneumocystis
- What is being tested?
- Spirulina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteZambia
- Study dates
- 1 Mar 2015to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All infants were eligible for the study if they are between 6 and 18 month of age
Who cannot join
- Non-singleton birth infants were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Spirulina Production and Utilization in Luapula Province of Zambia
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.
Read the 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
- Being tested
- Spirulina, Control
- Keywords
- Micronutrient supplementation, Home fortification, Spirulina, Zambia
- Medical subject headings
- Growth Disorders, Thinness, Pneumonia, Pneumocystis, Cough, Malaria, Fever, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirulinaDietary 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.
ControlDietary supplement
Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.
| Study group | Role | What they receive |
|---|---|---|
| Spirulina (SP) | Experimental | Children in the SP group (n=251) received a soya-maize-based porridge for 12 months with the addition of spirulina. Receives: 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. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Secondary outcome is changes in WAZ. Weight of the infants is transformed to standardized scores using the WHO Multicentre Growth Standards
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At 24 month follow up survey (April 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Mar 2015
- Primary completion30 Apr 2016
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Programme Against Malnutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Hitotsubashi University, Alliance Forum Foundation
- Responsible party
- Sponsor
- Investigators
- Kazuya Masuda, PhD, Principal investigator, Hitotsubashi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523182
- Sponsor's protocol ID
- FWA00000338
- Status last verified
- Feb 2019
- First submitted
- 19 Apr 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Spirulina Production and Utilization in Luapula Province of Zambia
- ClinicalTrials.gov ID
- NCT03523182
- Acronym / sponsor ID
- FWA00000338
- Conditions
- Stunting, Underweight, Pneumonia, Pneumocystis, Cough, Malaria, Fever
- Keywords
- Micronutrient supplementation, Home fortification, Spirulina, Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Programme Against MalnutritionUniversity, hospital or other
- Collaborators
- Hitotsubashi University, Alliance Forum Foundation
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirulina (SP) | Experimental | Dietary Supplement: Spirulina, Dietary Supplement: ControlChildren in the SP group (n=251) received a soya-maize-based porridge for 12 months with the addition of spirulina. |
| Control (CON) | Active comparator | Dietary Supplement: ControlChildren in the CON group (n=250) received a soya-maize-based porridge for 12 months. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All infants were eligible for the study if they are between 6 and 18 month of age
Key exclusion criteria (1 listed)
- Non-singleton birth infants were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirulinaArthrospira 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. | Dietary supplement | Spirulina (SP) |
| ControlChildren receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend. | Dietary supplement | Control (CON), Spirulina (SP) |
Primary outcome
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
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.
7 secondary outcomes
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)
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)
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)
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)
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)
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
Child development at 24 month follow up
Time frame: At 24 month follow up survey (April 2017)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuya Masuda, PhD principal investigator
Hitotsubashi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina in people with Stunting and Underweight, run by Programme Against Malnutrition at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.