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 (NCT) | NCT00133419 |
| Protocol serial number | 5U01 AI058371-05 (grant number); NIH/NIAD |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) (USA) |
| Funder | National Institute of Allergy and Infectious Diseases (NIAID) (USA) |
- 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
Scientific
Africa Centre for Health and Population Studies
P.O. Box 198
Mtubatuba
3935
South Africa
| Phone | +27 (0)35 550 7502 |
|---|---|
| mbennish@africacentre.ac.za |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A randomised, double blind, clinical controlled trial with three arms |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Months |
| Upper age limit | 6 Months |
| Sex | |
| Target sample size at registration | 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
3935
South Africa
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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
