Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/04/2015
Date assigned
12/05/2015
Last edited
08/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When infants aged 6-24 months from low-income countries start eating a wide range of foods in addition to breast milk (weaning), they often develop a number of nutritional and health problems. This is because the food they are eating is low in essential nutrients, which may result in poor growth and development, and an increase in common childhood illnesses such as diarrhoea. The typical diet for weaning in such countries is made up of starchy foods, such as a cereal (maize, rice) or tuber vegetables (cassava, yams). There are limited amounts of fruits, vegetables, legumes, and pulses available and very little meat or dairy foods. Moringa oleifera, an edible tree commonly found in dry tropical regions, has been shown to be a valuable source of nutrients, including protein, calcium, iron, vitamin C, and vitamin A. The moringa leaf can be made into a powder to be combined with flour or used as ‘sprinkles’ to mix with other food. As a result, it is used more and more as a food supplement in developing countries where poor nutrition is a major concern. The aim of this study is to see whether moringa leaf powder affects growth and weight gain in weaning infants from Asesewa, Ghana, an area with very high rates of infant malnutrition.

Who can participate?
Carers with weaning infants aged 8-12 months.

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (intervention group) are given a 35g daily ration of cereal legume flour with added moringa leaf powder. Those in group 2 (intervention group) are given a 5g daily ration of moringa leaf powder. Those in group 3 (control group) are given a 35g daily ration of cereal legume flour without moringa leaf powder. All participants are given nutrition education by a trained researcher. Questionnaires and interviews are used at the start of the study to assess home life and health history of participating infants and carers. All infants’ have weight and height measurements and a finger prick blood test at the start and end of the study. Families are visited by a researcher every 2 weeks for four months.

What are the possible benefits and risks of participating?
The results of this study will be very useful in informing recommendations for improving the quality of foods fed to infants after the first 6 months of life when weaning foods are introduced. Infants will receive study foods free of charge as well as nutrition education on how to feed infants hygienically. There are no foreseeable risks to participation in this study. The finger prick test may bring temporary discomfort to infants, but it is carried out by a qualified and trained researcher.

Where is the study run from?
University of Ghana Nutrition Research and Training Centre (Ghana)

When is the study starting and how long is it expected to run for?
September 2014 to November 2015

Who is funding the study?
International Development Research Centre (Canada)

Who is the main contact?
Mrs L Boateng

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Laurene Boateng

ORCID ID

http://orcid.org/0000-0003-3195-6040

Contact details

PO BOX
Accra
+233
Ghana

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GHS-ERC 07/09/14

Study information

Scientific title

Effect of complementary foods that incorporate moringa leaf powder, on growth and micronutrient status of Ghanian infants from age 8-12 months: a randomised controlled trial

Acronym

Study hypothesis

Infants fed moringa leaf powder either as part of cereal-legume blended flour or as a food supplement for 4 months will have significantly higher weight and length gain, haemoglobin levels and vitamin A levels, than infants fed the cereal-legume blended flour without moringa.

Ethics approval

1. Noguchi Memorial Institute for Medical Research - Institutional Review Board, 17/07/2014, ref: NMIMR –IRB CPN -106/14-14.
2. Ghana Health Service - Ethics Review Committee, 22/11/2014, ref: GHS-ERC: 07/09/14.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Protein-energy malnutrition and micro-nutrient malnutrition.

Intervention

1. Group 1 (treatment): 35g daily ration of cereal legume flour with moringa leaf powder plus nutrition education.
2. Group 2 (treatment): 5g daily ration of moringa leaf powder plus nutrition education.
3. Group 3 (control): 35g daily ration of cereal legume flour without moringa leaf powder plus nutrition education.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Haemoglobin levels after 4 months of daily feeding

Secondary outcome measures

Growth after 4 months of daily feeding

Overall trial start date

09/09/2015

Overall trial end date

30/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants aged between 8-12 months
2. Infant is breastfed
3. Caregiver of infant is willing to stay in the study area for the next 4 months
4. Infant tolerates ingredients in the study foods (maize, soya bean, dark green leafy vegetables).

Participant type

Carer

Age group

Child

Gender

Both

Target number of participants

411

Participant exclusion criteria

1. Infant below 8 months or older than 12 months
2. Infant not breastfed
3. Caregiver of infant is unwilling to stay in the study area for the next 4 months
4. Infant is unable to tolerate ingredients in the study foods (maize, soya bean, dark green leafy vegetables).

Recruitment start date

10/12/2014

Recruitment end date

31/07/2015

Locations

Countries of recruitment

Ghana

Trial participating centre

University of Ghana Nutrition Research and Training Centre
Asesewa
-
Ghana

Sponsor information

Organisation

International Development Research Centre

Sponsor details

150 Kent Street
Ottawa
ON
Canada K1P 0B2
Ottawa
K1G 3H9
Canada

Sponsor type

Research organisation

Website

Organisation

University of Ghana

Sponsor details

Department of Nutrition and Food Science
Legon
Accra
+233
Ghana

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

International Development Research Centre

Alternative name(s)

Centre de recherches pour le développement international, IDRC

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Results and Publications

Publication and dissemination plan

Findings of the study will be presented at the Department of Nutrition and Food Science, University of Ghana. I will also present preliminary results at the National Health Research Symposium in Ghana in May, 2015. Findings will also be presented at the FAO headquarters in Rome. FAO is very much interested in using food-based approaches to improve dietary intakes thus the results of this study will be of immense interest and may be beneficial in shaping policy on infant feeding. At least 3 manuscripts on the work will be submitted to a professional journals starting from January, 2015.

Intention to publish date

01/06/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes