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Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523182
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Hitotsubashi University
Alliance Forum Foundation
Information provided by (Responsible Party):
Programme Against Malnutrition

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.


Condition or disease Intervention/treatment Phase
Stunting Underweight Pneumonia, Pneumocystis Cough Malaria Fever Motor Delay Dietary Supplement: Spirulina Dietary Supplement: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Spirulina Production and Utilization in Luapula Province of Zambia
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : January 30, 2018


Arm Intervention/treatment
Experimental: Spirulina (SP)
Children in the SP group (n=251) received a soya-maize-based porridge for 12 months with the addition of spirulina.
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.


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

Active Comparator: Control (CON)
Children in the CON group (n=250) received a soya-maize-based porridge for 12 months.
Dietary Supplement: Control
Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523182


Locations
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Zambia
Programme Against Malnutrition
Mansa, Luapura, Zambia
Sponsors and Collaborators
Programme Against Malnutrition
Hitotsubashi University
Alliance Forum Foundation
Investigators
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Principal Investigator: Kazuya Masuda, PhD Hitotsubashi University
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Responsible Party: Programme Against Malnutrition
ClinicalTrials.gov Identifier: NCT03523182    
Other Study ID Numbers: FWA00000338
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Programme Against Malnutrition:
Micronutrient supplementation
Home fortification
Spirulina
Zambia
Additional relevant MeSH terms:
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Pneumonia, Pneumocystis
Pneumonia
Thinness
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Body Weight
Signs and Symptoms