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 designA randomised, double blind, clinical controlled trial with three arms
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleMicronutrients 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 objectivesObjective:
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) studiedHuman Immunodeficiency Virus (HIV)
InterventionChildren 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 typeSupplement
Primary outcome measureThe 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 measuresNo secondary outcome measures
Overall study start date01/07/1999
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Months
Upper age limit6 Months
SexNot Specified
Target number of participants516
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/1999
Date of final enrolment30/06/2005

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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