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 |
| Secondary identifying numbers | SCC 1135v2 |
- 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
Scientific
MRC Laboratories
PO Box 273
Fajara
Banjul
-
Gambia
| sunger@mrc.gm |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 15/09/2009 |
| Completion date | 15/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 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
-
Gambia
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
MRC London Centre
Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom
| andrew.prentice@lshtm.ac.uk | |
| Website | http://www.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) - International Nutrition Group (ING) Core Funding
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
17/08/2017: Publication reference added.
