ISRCTN - ISRCTN73571031: The effects of lipid-based multiple micronutrients on the health of children in the developing world

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefan Unger

ORCID ID

Contact details

MRC Laboratories
PO 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, 27/03/2009, 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 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 measure

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 (if study stopped)

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 type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type