Condition category
Infections and Infestations
Date applied
30/03/2006
Date assigned
30/03/2006
Last edited
04/08/2008
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

Prof M L Bennish

ORCID ID

Contact details

Africa Centre for Health and Population Studies
P.O. Box 198
Mtubatuba
3935
South Africa
+27 (0)35 550 7502
mbennish@africacentre.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00133419

Protocol/serial number

5U01 AI058371-05 (grant number); NIH/NIAD

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

A randomised, double blind, clinical controlled trial with three arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Micronutrient supplementation

Primary outcome measures

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 trial start date

01/07/1999

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

516

Participant 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

Recruitment start date

01/07/1999

Recruitment end date

30/06/2005

Locations

Countries of recruitment

South Africa

Trial participating centre

Africa Centre for Health and Population Studies
Mtubatuba
3935
South Africa

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

http://www.niaid.nih.gov/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

NIAID

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

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

Publication citations

Additional files

Editorial Notes