Effect of nutritional supplements on lean body mass, general health and disease progression of human immunodeficiency virus (HIV) positive lactating mothers and the ensuing effects on their infants including the impact of feeding mode on disease progression in the infected infants
| ISRCTN | ISRCTN68128332 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68128332 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/01/2011
- Registration date
- 07/02/2011
- Last edited
- 06/06/2012
- 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
Dr Gurpreet Kindra
Scientific
Scientific
Room 257, 2nd floor
DDMRI Building
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
Durban
4013
South Africa
Study information
| Study design | Prospective observational study with a nested randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of nutritional supplements on lean body mass, general health and disease progression of human immunodeficiency virus (HIV) positive lactating mothers and the ensuing effects on their infants including the impact of feeding mode on disease progression in the infected infants: a prospective observational study with a nested randomised controlled trial |
| Study objectives | 1. Breastfeeding will not negatively impact on mothers' lean body mass; nutritional status; disease progression and psychological indices 2. Exclusive breastfeeding versus formula feeding will reduce diarrhoeal morbidity; improve growth and developmental indices in the HIV exposed negative infants and would improve outcome in HIV infected infants 3. Nutritional supplementation provided to HIV infected lactating women will improve their lean body mass; nutritional status and health 4. Nutritional supplementation provided to HIV infected lactating women will improve the quality of breastmilk |
| Ethics approval(s) | University of KwaZulu-Natal, Durban, Ethics Committee approved on the 6th May 2006 (ref: H081/05) |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus (HIV) |
| Intervention | The intervention used was a ready to use micronutrient enriched peanut/soy milk food paste available locally and being used by our national department of health as a supplement in HIV wasting and malnutrition. It was donated to us by the "Gift of the givers" foundation (website: http://www.giftofthegivers.org/). The supplement is called Sibusiso ready food supplement. Daily dose of the supplement was 50g orally. The total duration the supplement was given was 6 months and the follow-up of all patients was 9 months. The control arm received non-nutritive supplements like tea, soap, shampoo. |
| Intervention type | Other |
| Primary outcome measure | 1. Clinical assessments including WHO disease staging and anthropometric measurements (weight, length/height, mid-upper arm circumference, triceps skinfold thickness and head circumference [infants]) were done at baseline and monthly till six months and last visit at nine months in both mother and child 2. CD4 counts and laboratory assessments at baseline and six months in the mother 3. Body composition measurements in mothers every at baseline and every three months till nine months using: saliva samples and deuterium enrichment method (FTIR - Fourier transform infra red spectroscopy) and BIA (Bioelectrical Impedance analysis) 4. The WHO Self reporting questionnaire (SRQ 20) and 24 hour dietary recall every three months in the mother 5. Infant feeding history at baseline and monthly till six months, then at nine months 6. HIV DNA PCR was done on the child at six weeks and nine months. If positive at six weeks, it was repeated at ten weeks. CD4 counts and safety bloods were done on all positive infants to assess for antiretroviral eligibility and to start treatment. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 20/11/2006 |
| Completion date | 15/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 192 |
| Key inclusion criteria | 1. HIV positive pregnant women 2. Not yet eligible for antiretroviral therapy, i.e., World Health Organization (WHO) Stage 1 or 2; or CD4 greater than 200 3. Resident in Cato Manor area in Durban, KwaZulu-Natal |
| Key exclusion criteria | 1. Women who had advanced disease (CD4 less than 200 or WHO stage 3 and 4 disease) were not eligible for participation and were referred to the anti-retroviral (ARV) treatment programme on site 2. Women who did not intend to stay within a 30 km radius of the clinic and would not be able to attend follow up visits 3. Any mother who gave birth to a baby with any congenital abnormality or with any complication during birth requiring specialized management 4. Gestation less than 36 weeks |
| Date of first enrolment | 20/11/2006 |
| Date of final enrolment | 15/04/2009 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Room 257, 2nd floor
Durban
4013
South Africa
4013
South Africa
Sponsor information
University of KwaZulu-Natal (South Africa)
University/education
University/education
The Chair
Bioethics Research Committee
Room N40, Govan Mbeki Building
Westville campus
Durban
3629
South Africa
| Website | http://research.ukzn.ac.za/ |
|---|---|
"ROR" |
https://ror.org/04qzfn040 |
Funders
Funder type
Industry
Hasso Plattner Ventures (Germany) - fund administered through the University of KwaZulu-Natal, for consumables
No information available
International Atomic Energy Agency (IAEA) (USA) - funded all equipment used in the study
No information available
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 | 22/12/2011 | Yes | No |
