Micronutrients and enteric infections in African children: the effect of prophylactic micronutrient supplementation on morbidity and growth in human immunodeficiency virus infected and human immunodeficiency virus-uninfected children in South Africa

ISRCTN	ISRCTN39226623
DOI	https://doi.org/10.1186/ISRCTN39226623
ClinicalTrials.gov number	NCT00133419
Secondary identifying numbers	5U01 AI058371-05 (grant number); NIH/NIAD

Submission date: 30/03/2006
Registration date: 30/03/2006
Last edited: 28/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof M L Bennish
Scientific

Africa Centre for Health and Population Studies
P.O. Box 198
Mtubatuba
3935
South Africa

Phone	+27 (0)35 550 7502
Email	mbennish@africacentre.ac.za

Study information

Study design	A randomised, double blind, clinical controlled trial with three arms
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Micronutrients and enteric infections in African children: the effect of prophylactic micronutrient supplementation on morbidity and growth in human immunodeficiency virus infected and human immunodeficiency virus-uninfected children in South Africa
Study objectives	Objective: To compare the effect of three micronutrient supplements: 1. Vitamin A only, 2. Vitamin A and zinc, 3. A micronutrient mixture containing vitamins A, B, C, D, E, K, and calcium, copper, folate, iodine, iron, magnesium and zinc, on prevalent days of diarrhoea in three groups of children: a. Human Immunodeficiency Virus (HIV)-infected children b. HIV-uninfected children born to HIV-infected women c. HIV-uninfected children born to women without HIV infection
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Human Immunodeficiency Virus (HIV)
Intervention	Children from each of the HIV status groups will be individually randomised to one of the three multivitamin/micronutrient arms: 1. Vitamin A only 2. Vitamin A and zinc 3. A micronutrient mixture containing vitamins A, B, C, D, E, K, and calcium, copper, folate, iodine, iron, magnesium and zinc Randomisation will occur in blocks of six within each of the HIV status groups. This will result in assigning a pre-coded box filled with blister packets of seven micronutrient tablets each. Each child will use tablets from that same box throughout the study. Each type of tablet will appear and taste identical to ensure blinding of both mothers and field staff. The interval between testing and randomisation may vary depending on the time required to obtain HIV testing results. All children will, however, start their respective supplement at six months of age (+/- 14 days) and will continue with the supplements until they are 24 months of age (i.e. for approximately 18 months). Monitoring will continue throughout this time to determine the long-term impact of each supplementation.
Intervention type	Supplement
Primary outcome measure	The primary outcome measure is prevalent days of diarrhoea per child during the 18 months that children will receive supplements (from six to 24 months of age). Comparisons will be stratified by HIV status, and all three micronutrient regimens will be compared within these strata.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/07/1999
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Months
Upper age limit	6 Months
Sex	Not Specified
Target number of participants	516
Key inclusion criteria	1. Infants aged four to six months (stratified by HIV status) 2. Able to take oral preparations 3. Parent/guardian able to give consent
Key exclusion criteria	1. Documented micronutrient supplementation other than vitamin A in the preceding month 2. Less than 60% of mean weight for age by National Center for Health Statistics (NCHS) guidelines (micronutrient intervention obligatory according to World Health Organisation [WHO] guidelines for management of severely malnourished children) 3. Persistent diarrhoea (more than seven days) at the time of study enrolment 4. Exclusive breastfeeding 5. Infants in whom a second confirmatory HIV test cannot be obtained (when required) 6. Co-enrolment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials
Date of first enrolment	01/07/1999
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

South Africa

Study participating centre

Africa Centre for Health and Population Studies

Mtubatuba
3935
South Africa

Sponsor information

National Institute of Allergy and Infectious Diseases (NIAID) (USA)
Government

International Tropical Disease Research Network
Division of Microbiology and Infectious Diseases (DMID)
Room 5067
6610 Rockledge Drive
Bethesda
20892
United States of America

Website	http://www.niaid.nih.gov/
"ROR"	https://ror.org/043z4tv69

Funders

Funder type

Government

National Institute of Allergy and Infectious Diseases (NIAID) (USA)
Government organisation / National government

Alternative name(s): Instituto Nacional de Alergias y Enfermedades Infecciosas, National Institute of Allergy & Infectious Diseases, NIAID
Location: United States of America

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	27/06/2007	28/01/2019	Yes	No
Results article	results	01/07/2009	28/01/2019	Yes	No
Results article	results	18/03/2010	28/01/2019	Yes	No

Editorial Notes

28/01/2019: Publication reference added