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

ISRCTN	ISRCTN73571031
DOI	https://doi.org/10.1186/ISRCTN73571031
Protocol serial number	SCC 1135v2
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK) - International Nutrition Group (ING) Core Funding

Submission date: 22/06/2009
Registration date: 30/07/2009
Last edited: 17/08/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stefan Unger
Scientific

MRC Laboratories
PO Box 273
Fajara
Banjul
-
Gambia

Email	sunger@mrc.gm

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	MMCT
Study objectives	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(s)	Medical Research Council (MRC) and the Gambian Government Ethics Committee, 27/03/2009, ref: SCC1135v2
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Micronutrient status and standard haematology in a random subgroup of 300 subjects, measured at day 10 and at 12 weeks from start of supplementation.
Completion date	15/09/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	5 Years
Sex	All
Target sample size at registration	2250
Key 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
Key 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)
Date of first enrolment	15/09/2009
Date of final enrolment	15/09/2011

Locations

Countries of recruitment

Gambia

Study participating centre

MRC Laboratories

Banjul
-
Gambia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/08/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/08/2017: Publication reference added.