Multiple micronutrient supplementation using spirulina platensis and infant growth, morbidity, and motor development: Evidence from a randomized trial in Zambia

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. This study aimed 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. We randomly assigned 501 Zambian infants into the control group or the spirulina group. Children in the control group (n = 250) received a soya-maize-based porridge for 12 months; those in the spirulina group (n = 251) received the same food with the addition of spirulina. We assessed the change in infants’ anthropometric status, morbidity (probable pneumonia, cough, probable malaria, and fever), and motor development over 12 months. The baseline characteristics were not different between the two groups. The attrition rate (47/501) was low. The physical growth of infants in the two groups was similar at 12 months of intervention, as measured by height-for-age z-scores and weight-for-age z-scores. Infants in the spirulina group were 11 percentage points less likely to develop a cough (CI: -0.23, -0.00; P < 0.05) and were more likely to be able to walk alone at 15 months (0.96 ± 0.19) than infants in the control group (0.92 ± 0.28). Home-fortification of complementary foods using spirulina had positive effects on upper respiratory infection morbidity prevention and motor milestone acquisition among Zambian infants.


Background and Introduction
Infant and child malnutrition is one of the most serious health problems in developing countries. Malnutrition impairs a child's physical and mental development and can result in lower IQ and compromised immunity. Lancet Series (2013) reported that 45 % of children's deaths in developing countries are caused by malnutrition.
According to the World Health Organization, underweight in low-income countries is a major health risk in infants and young children.
Sub-Saharan Africa has one of the most serious rates of chronic malnutrition in the world. In Zambia, chronic malnutrition or stunting affects 45 % of the under five children. This remains the most common nutritional disorder, being slightly above the Sub-Saharan Africa's average of 42 % (CSO, 2009) and the eighth highest rate in the world (UNICEF, 2013). In addition, micronutrient deficiencies are having an enormous impact on children's health. Around 50-55% of the children in Zambia suffer from vitamin A deficiency and iron deficiency (CSO, 2009). On the contrary, indicators of acute malnutrition remain comparatively low. Five per cent of Zambian children are wasted while 15 % are underweight (CSO, 2009).
The Zambian nutrition profile shows that 60 % of households cannot afford 3 meals per day (FAO, 2009) which leads to inadequate nutrient intake and malnutrition.
The same research shows that in the period 2000-2002, the dietary energy supply was only 1,905 kcal per capita/day (FAO, 2009). This clearly shows that households do not therefore meet the estimated necessary energy requirement of 2,056 kcal per capita/day.
Carbohydrates such as cereals and starchy roots are the main source of energy which account for 80 % of the total energy intake (FAO, 2009). This suggests that the intake of other essential nutrients as well as protein and lipids is generally insufficient.

Rationale for study
Spirulina is a blue-green micro algae indigenous to Africa that has the potential to meet the nutrition demand of Zambians. Spirulina contains high percentage of protein, minerals, and vitamins necessary to support children's growth. The cost of production to get the same amount of protein is much lower than that of other protein-rich foods, such as soya beans and beef, see Figure 1 below. Participating children showed that spirulina makes a statistically significant difference in height between Treatment Group and Control Group (height higher in Treatment Group). Thus, the effectiveness of Spirulina to lower the rate of stunting in Zambia was suggested. Further, there was the unexpected but positive reduction in cases of malaria among the treatment group compared to the control group during the study period.
Based on the study results, the Ministry of Health recommended the need to scale up the study to gain wider support in promoting spirulina. Therefore, this project called Promoting Spirulina Production and Utilization in Luapula Province was approved by CARE International in Zambia to validate the effectiveness of spirulina among malnourished children under the age of two years in Mansa and Samfya districts.
The objective of the project is to increase access and consumption of spirulina to contribute to reduce the rate of stunting in children below two years of age in Luapula province by 2016.

Significance
The Zambian Government's aim is to lower the rate of stunting among children under the age of five from 45 % to 30 % by 2015. Available data shows a decline in child malnutrition from 1992 to 2007, but the slight increase again in stunting in 2010 shows that there is need for more concerted effort if Zambia to meet its 2015 target.
Spirulina has the potential to expedite the Zambian Government's effort. Spirulina contains many nutrients important for child growth such as protein, beta carotene, iron, thiamine, riboflavin, Vit. B6, Vit. B12, selenium and calcium among other nutrients.
In the long-term, reducing the rate of stunting will benefit the Zambian economy. According to the National Food and Nutrition Commission (NFNC, 2012), Zambia has lost US$ 775 million in economic production due to the high rates of stunting over the 10 year period of 2004-2013. Further, the UNICEF report (2010 found that stunted children are more prone to diseases, often lag behind in class, become overweight in adulthood and are thus more susceptible to non-communicable diseases, and are more likely to earn less than non-stunted co-workers. 1 Although much effort has been made by government to reduce stunting, it is a daunting task to cover all the target population by public effort. This project is thus aimed at complementing government's effort in the fight against malnutrition in line with the First 1000 Most Critical Days Programme (First 1000 MCDP) priority interventions.

Aim
The second spirulina effectiveness test will be conducted as a part of the project "Promoting Spirulina Production and Utilization in Luapula Province of Zambia", which is the donor funded Scaling Up Nutrition (SUN) Programme. The main purpose of the project is to scale up and validate the effectiveness of spirulina in malnourished children under the age of two years in Mansa and Samfya districts of Luapula Province.

Specific objectives
The specific objectives of the project are:

Target Population
The target population of the proposed study is households with children between 6 and 24 months old.

Selection of Participants
 Collection of baseline data (height, weight, MUAC, socio-economic survey, dietary diversity survey, morbidity survey) from the households who signed to the consent form.  Random Selection of a total of 500 children between the age of 6-24 months from the households who signed to the consent form.  Random division of the children into two groups by assigning them to either treatment group or control group.

Intervention
 Provision of 10g of spirulina per day to the treatment group children for one year.
(Spirulina will be mixed with mealie meal for porridge. The control group children will receive plain porridge blend for the same period).

Data Collection
 Collection of socio-economic data of participating children and their households at baseline.  Anthropometry i.e. weight, height, and mid upper arm circumference at baseline, midline, and endline.  Collection of morbidity history of treatment and control group children every month for one year.  Collection of 7 day dietary recall data of treatment and control group children every three months for one year.

Data Analysis
 Analysis of the difference in body measurements, and morbidity history between the treatment group and the control group to see if spirulina had any effect on improving nutrition. Socio-economic data and dietary habit data will be used to exclude non-spirulina effect.

Duration
The project period is 15 months from April 2015 -June 2016

Assessment Criteria
The area of questions to be asked at the Effectiveness Test is listed in the Morbidity History Ask history of the child's vaccinations and the child's and mother's morbidity history in the past 4 weeks (e.g. pneumonia, diarrhoea, measles, malaria)

Training
Project officers, stakeholders and child growth promoters will be sensitized on the First 1000 MCDP to enhance their understanding of nutrition issues. Further, the officers and child growth promoters will be trained in nutrition, anthropometry i.e.
height, weight and mid-upper arm circumference, spirulina porridge blend preparation and cooking of other spirulina based foods and data collection. Training will promote ownership of the project and enhance accurate data collection.

Detailed Ethical issues 1. Voluntary participation:
Households will make an informed choice after project sensitization and request to participate in the study. Participation in the project will be voluntary and participants' views will be fully respected throughout the project.

2.Informed consent:
Households will be availed with details on the benefits and some of the risks that could be associated with consuming spirulina using the Bemba information sheets before they endorse their participation. Bemba consent forms will be signed as proof of having discussed the details of the project and consent to participate.
In case the participant does not speak either English or Bemba, PAM will make sure there is an interpreter to help participants understand the objectives of the study before getting the consent and proceeding with the interview.

Confidentiality:
All the documents and records concerning personal information will be strictly stored at PAM office in Lusaka or Mansa to maintain confidentiality.

Anonymity:
It will not be possible to keep participants' anonymity among AFF and PAM staff because of the need to understand the difference in lifestyle and nutritional knowledge by income and area of residence. However, personal information will be strictly confidential.  2. I had the time to consider the information and to ask questions which were answered satisfactorily.

Budget
3. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.
4. I understand that relevant sections of any of my data collected during the project may be looked at by responsible individuals from Programme Against Malnutrition (PAM), Alliance Forum Foundation (AFF) or from regulatory authorities, where my data may be relevant during the course of this research. I give permission for these individuals to have access to my records.
5. I agree to take part in the above research project.

Guide for Interviewers
This document was created for interviewers to review before going into the field for an interview.

Courtesy
 Dress up neatly on the interview days.
 Be polite to households you visit. Pay particular attention and respect their schedule and health. For example, ask convenient time for conducting the interview. If the interviewee expresses any health issue, schedule for another day of visit and do not push them.  Be clear on the issues of confidentiality and rights of the interviewee before questioning by using the information sheet.

Plan
 Note the time when to collect particular data throughout the year. Especially, be aware of three different types of questionnaires-monthly, quarterly, and semi-annually, so that you can get the right information at the right time.  Schedule when to visit which zone every month in consultation with the Rural Health Centre.

Review
 Review the questionnaire sheet each day before and after going into the field.
 Summarize what each questionnaire is all about so that you do not get confused in front of the interviewee.  Take note of any challenges encountered in the field and share them with colleagues and PAM staff for appropriate decisions to be made.

Section 4-b. Consumption and Expenditure on Major Items (Non-Durable Goods) in the Past 12 Months
Instruction: *If the household does not purchase the item, ask how much the household would pay for the item per kg. ** EX0=23 -42, ask only total expenditure. CHECK Unit code in code sheet in the last page.

Dietary Diversity Record: For Data Entry
Household ID Did this child eat foods from Group 1, Group 2, Group 3, Group4, Group 5, Group 6, Group 7, respectively for 3 or more days in previous 7 days?

Monthly Compliance Record Survey (April 2015)
Instruction: Ask the mother of the target child "Did you feed the distributed porridge (with spirulina or without spirulina) to the target child last Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, and Sunday, respectively.

ID
Compliance Did you feed the child the distributed porridge last … 1=Yes 0=No How many days did the mother feed the child the distributed porridge during the last 7 days?

CO-ORDINATION
 Link person between GCDMO and other organizations dealing in food and nutrition aspects in the area and overseer of nutrition activities carried out by nutrition groups in the district and also build partnership with other stake holders.
 Establish and maintain contact with the nutrition specialist at ministry of health and other stake holders.

OTHER ACTIVITIES (ELECTROL COMMISSION OF ZAMBIA)
