Spirulina Supplementation and Infant Growth, Morbidity and Motor Development

P

Programme Against Malnutrition

Status

Completed

Conditions

Fever
Cough
Pneumonia, Pneumocystis
Malaria
Stunting
Underweight
Motor Delay

Treatments

Dietary Supplement: Control
Dietary Supplement: Spirulina

Study type

Interventional

Funder types

Other

Identifiers

NCT03523182
FWA00000338

Details and patient eligibility

About

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.

Full 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.

Enrollment

501 patients

Sex

All

Ages

6 to 18 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

501 participants in 2 patient groups

Spirulina (SP)
Experimental group
Description:
Children in the SP group (n=251) received a soya-maize-based porridge for 12 months with the addition of spirulina.
Treatment:
Dietary Supplement: Spirulina
Dietary Supplement: Control
Control (CON)
Active Comparator group
Description:
Children in the CON group (n=250) received a soya-maize-based porridge for 12 months.
Treatment:
Dietary Supplement: Control

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems