Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/02/2014
Date assigned
12/03/2014
Last edited
12/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It has been shown that solid ready-to-use food supplements are very effective in treating severe malnutrition in developing countries. They promote weight gain and increase in energy intake, which is higher when compared to changes caused by drinking medicinal high-energy milk-based drinks. However, their efficiency in treating moderate/mild malnutrition remains unknown. This study aims to compare the efficiency of high-energy, nutritional, solid, ready-to-eat supplements and liquid, milk-based supplements on the weight gain of children

Who can participate?
Children aged between 5-10 years with mild to moderate malnutrition from the participating primary schools.

What does the study involve?
School children will be randomly selected and then height and weight measurements will be taken. Children with mild to moderate malnutrition will be invited to participate in the study. The children will be randomly allocated to receive either solid ready-to-use food (Plumpy’ Nut) or liquid ready-to-use supplement (Fortini, Nutricia). Children will be given these supplements in their school for four weeks and will be asked to consume the supplements in addition to their usual diet. The children will be asked to keep the empty bottles/sachet of the supplements with them after drinking/eating, which will be collected by the main researcher next day in order to check the compliance. Any leftover in the bottle or sachet will be recorded. Height, weight, biceps and triceps skin folds and mid-upper-arm circumference of the child will be measured before the supplementation, two weeks after starting the supplementation and at the end of the supplementation. The child will fill in an appetite questionnaire before taking the first and the last supplement. Further, the parent/carer will be requested to attend a focus group regarding the appetite of their child once before the start of supplementation and once at the end of the study. At the end of the study, the children who were screened and did not meet the criteria for recruitment will be measured for height and weight.

What are the possible benefits and risks of participating?
There will be no major benefits or risk of participating. The parent/carer may benefit by finding out about their child’s body measurements and receive information regarding their child’s nutritional status before and after supplementation. As dietary counselling is a fundamental and effective part of the treatment of mild to moderate malnutrition, the parent/carer will get some counselling on the completion of the study. There might be a risk of allergic reaction from the peanut butter used in the preparation of solid ready-to-use food. However, an allergic reaction will be rare as peanuts are part of the traditional diet of the participants and the eligible children and their parents will be asked to complete a health questionnaire.

Where is the study run from?
The study is run from primary schools of Abbottabad district located in the Hazara region of Khyber
Pakhtunkhwa province in Pakistan.

When is the study starting and how long is it expected to run for?
The study will start in March 2014 and is expected to be completed by August 2014.

Who is funding the study?
University of Glasgow, UK.

Who is the main contact?
Dr Konstantinos Gerasimidis, Konstantinos.Gerasimidis@glasgow.ac.uk
Professor Charlotte Wright, charlotte.wright@glasgow.ac.uk
Dr Sadia Fatima, s.fatima.1@research.gla.ac.uk ‎

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sadia Fatima

ORCID ID

Contact details

Human Nutrition Section
School of Medicine College of Medical
Veterinary and Life Sciences (MVLS)
New Lister Building
Glasgow Royal Infirmary10-16 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
s.fatima.1@research.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of the effectiveness of solid ready-to-eat and a liquid ready-to-drink supplements for management of mild to moderate malnutrition in children from Pakistan: a randomized trial

Acronym

Study hypothesis

To compare the efficacy of solid ready to eat and liquid ready to drink supplements in promoting weight gain in mild to moderate malnourished children.

Ethics approval

The College of Medical Veterinary and Life Sciences, University of Glasgow, Research Ethics Committee, 14/05/2013
The Research Ethics Committee of Ayub Medical College Abbottabad 05/05/2013

Study design

Open labelled randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Participant’s information material is not available in web format; please contact s.fatima.1@research.gla.ac.uk to request participant’s information.

Condition

Mild and Moderate Malnutrition

Intervention

The participants are receiving either solid ready to use food (RTUF) (Plumpy’ Nut; Nutriset, Malaunay, France), or liquid ready to use supplement (LRUS) (Fortini, Strawberry, Nutricia).
The total duration of the intervention is 4 weeks.

A solid ready to use food (RTUF) and liquid ready to drink supplement (LRUS) will be provided to the children for four weeks. LRUS is a strawberry flavoured ready to drink sip feed available in 200 ml bottles with a flexible straw, and RTUF is individually packaged in airtight alu-foil sachet, looks like a thick paste and tastes like a slightly sweeter peanut butter. Daily the children in RTUF group will be provided with one sachet of RTUF (92 g, 500 kcal/d), and the children in LRUS group will be provided with two bottles of LRUS (60 ml of LRUS will be removed daily from one of the two bottles in order to provide nearly 500 kcal/ day).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Weight measurement - The weight of the children will be measured wearing lightweight clothes without shoes with a calibrated electronic scale (Seca, Hamburg, Germany).
2. Height measurement - Height will be measured with a portable stadiometer (Seca, Leicester, UK) using a stretch stature method.
3. Mid upper arm circumference - Mid upper arm circumference will be measured with a flexible measuring tape on the left upper arm.
4. Skin fold measurement - Triceps, biceps and subscapular skin folds will be measured using Holtain skin fold calliper (Holtain LTD, Crosswell, UK) to the nearest 0.2 mm.
5. Appetite measures - Appetite sensations will be measured with validated appetite questionnaires (Flint et al., 2000).

All the primary outcomes will be measured before the supplementation (baseline), two weeks after initiation of the supplementation and at the end of the supplementation.

Secondary outcome measures

1. Taste acceptability of supplements
2. Perceived benefits of the supplements by parents/carers
3. Perceived side effects of the supplements by parents/carers

The secondary outcomes will be measured only before the supplementation (baseline) and at the end of supplementation.

Overall trial start date

01/03/2014

Overall trial end date

01/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary school children, aged between 5-10 years.
2. Mild to moderate malnutrition (Z-score between -2 and -1)
3. Healthy children
4. Not on any medication or on any nutritional supplements
5. Not following special diet

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

64

Participant exclusion criteria

1. History of eating disorder
2. History of gastrointestinal problems or surgery
3. History of food allergy
4. History of chronic illness
5. On any medication
6. Currently taking part in other research

Recruitment start date

01/03/2014

Recruitment end date

01/08/2014

Locations

Countries of recruitment

Pakistan

Trial participating centre

Human Nutrition Section
Glasgow
G31 2ER
United Kingdom

Sponsor information

Organisation

University of Glasgow (UK)

Sponsor details

Human Nutrition Section
School of Medicine College of Medical
Veterinary and Life Sciences (MVLS)
New Lister Building
Glasgow Royal Infirmary10-16 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
Dalia.Malkova@glasgow.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Glasgow (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes