Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Kelly

ORCID ID

Contact details

Tropical Gastroenterology & Nutrition Group
University of Zambia School of Medicine
Nationalist Road
Lusaka
-
Zambia
+260 1 252269
m.p.kelly@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

067948

Study information

Scientific title

Integrity of small intestinal antimicrobial defence in relation to micronutrients in Zambian adults

Acronym

Study hypothesis

To determine if a multiple micronutrient supplement boosts intestinal innate immunity in adults living in an urban environment in Africa.

Ethics approval

Obtained from two ethics committees:
1. University of Zambia Research Ethics Committee
2. London School of Hygiene and Tropical Medicine Research Ethics Committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Intestinal innate immunity

Intervention

Randomised, placebo-controlled trial of solid tablet formulation of 15 micronutrients, administered daily, with cross-over after two years.

The anticipated end date of this trial has been shortened to 1st January 2007, the previous anticipated end date was 31/08/2007.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Multiple micronutrient supplement

Primary outcome measures

1. Frequency of diarrhoeal disease
2. CD4 count in human immunodeficiency virus (HIV) seropositive participants
3. Expression of antimicrobial peptides in small intestinal tissue and secretions
4. Change in micronutrient status

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All adults (over 18 years of age, either sex) resident within a defined geographical area of Misisi compound, Lusaka, Zambia, have been invited to participate.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Zambia

Trial participating centre

Tropical Gastroenterology & Nutrition Group
Lusaka
-
Zambia

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7827 2678
Penny.Ireland@lshtm.ac.uk

Sponsor type

University/education

Website

http://www.lshtm.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 067948)

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

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18842788
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20604937
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24666552

Publication citations

  1. Results

    Kelly P, Katubulushi M, Todd J, Banda R, Yambayamba V, Fwoloshi M, Zulu I, Kafwembe E, Yavwa F, Sanderson IR, Tomkins A, Micronutrient supplementation has limited effects on intestinal infectious disease and mortality in a Zambian population of mixed HIV status: a cluster randomized trial., Am. J. Clin. Nutr., 2008, 88, 4, 1010-1017.

  2. Results

    Kelly P, Shawa T, Mwanamakondo S, Soko R, Smith G, Barclay GR, Sanderson IR, Gastric and intestinal barrier impairment in tropical enteropathy and HIV: limited impact of micronutrient supplementation during a randomised controlled trial., BMC Gastroenterol, 2010, 10, 72, doi: 10.1186/1471-230X-10-72.

  3. Results

    Kayamba V, Chomba M, Kelly P, Short term micronutrient-antioxidant supplementation has no impact on a serological marker of gastric atrophy in Zambian adults: retrospective analysis of a randomised controlled trial., BMC Gastroenterol, 2014, 14, 52, doi: 10.1186/1471-230X-14-52.

Additional files

Editorial Notes