Contact information
Type
Scientific
Primary contact
Dr Stefan Unger
ORCID ID
Contact details
MRC Laboratories
P.O Box 273
Fajara
Banjul
-
Gambia
sunger@mrc.gm
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCC 1135v2
Study information
Scientific title
A randomised controlled trial to investigate the effects of physician prescribed lipid-based multiple micronutrients on the health of children presenting to a primary health care centre in The Gambia
Acronym
MMCT
Study hypothesis
Physician prescribed lipid-based nutritional supplement (LNS) with a comprehensive set of micronutrients will improve the health status of children self-presenting to a primary health care clinic.
Ethics approval
Medical Research Council (MRC) and the Gambian Government Ethics Committee approved on the 27th March 2009 (ref: SCC1135v2)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Infant and child health status
Intervention
Randomised double-blind placebo-controlled trial of 25 g/d LNS (containing macronutrients and 23 micronutrients) under Good Clinical Practice (GCP) standards. Supplement will be administered by the carer. Compliance will be assessed by unannounced observations and questionnaires. Subjects will be randomised into three groups:
1. 12 week LNS supplementation
2. 6 week LNS supplementation followed by 6 week placebo
3. 12 week placebo
Each child will be followed up for 1 year.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Lipid-based nutritional supplement (LNS)
Primary outcome measures
Health status as indicated by the frequency of self-referred clinic return attendances within 12 months from baseline specifying clinical diagnoses at each presentation to profile disease patterns and growth (weight, height/length, mid-upper arm circumference (MUAC)) at four points over 6 months.
Secondary outcome measures
Micronutrient status and standard haematology in a random subgroup of 300 subjects, measured at day 10 and at 12 weeks from start of supplementation.
Overall trial start date
15/09/2009
Overall trial end date
15/09/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged 6 months - 5 years (either sex) from the West Kiang Region of The Gambia self-presenting to the clinic at MRC Keneba, West Kiang, The Gambia
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2250
Participant exclusion criteria
1. Children from regions other than the West Kiang Region of The Gambia
2. Children known to be asthmatic or allergic to peanuts
3. Children known to be involved in another trial
4. Children with known haemoglobinopathies
5. Children with severe malnutrition (weight-for-height SD-score less than -3 or/and presence of oedema) (World Health Organization [WHO] 2000)
6. Children presenting to the clinic but called rather than self-referred (e.g. for DSS purposes and immunisations)
Recruitment start date
15/09/2009
Recruitment end date
15/09/2011
Locations
Countries of recruitment
Gambia
Trial participating centre
MRC Laboratories
Banjul
-
Gambia
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
MRC London Centre
Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom
andrew.prentice@lshtm.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) - International Nutrition Group (ING) Core Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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