The impact of micronutrient supplementation on the health of Zambian adults with particular emphasis on intestinal infection

ISRCTN	ISRCTN31173864
DOI	https://doi.org/10.1186/ISRCTN31173864
Protocol serial number	067948
Sponsor	London School of Hygiene and Tropical Medicine (UK)
Funder	The Wellcome Trust (UK) (grant ref: 067948)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Paul Kelly
Scientific

Tropical Gastroenterology & Nutrition Group
University of Zambia School of Medicine
Nationalist Road
Lusaka
-
Zambia

Phone	+260 1 252269
Email	m.p.kelly@qmul.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Integrity of small intestinal antimicrobial defence in relation to micronutrients in Zambian adults
Study objectives	To determine if a multiple micronutrient supplement boosts intestinal innate immunity in adults living in an urban environment in Africa.
Ethics approval(s)	Obtained from two ethics committees: 1. University of Zambia Research Ethics Committee 2. London School of Hygiene and Tropical Medicine Research Ethics Committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/2003
Date of final enrolment	01/01/2007

Tropical Gastroenterology & Nutrition Group

Lusaka
-
Zambia

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/10/2008	Yes	No
Results article	results	06/07/2010	Yes	No
Results article	results	25/03/2014	Yes	No