Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
University of KwaZulu-Natal, Durban, Ethics Committee approved on the 6th May 2006 (ref: H081/05)
Study design
Prospective observational study with a nested randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
20/11/2006
Overall trial end date
15/04/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
192
Participant 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
Recruitment start date
20/11/2006
Recruitment end date
15/04/2009
Locations
Countries of recruitment
South Africa
Trial participating centre
Room 257, 2nd floor
Durban
4013
South Africa
Sponsor information
Organisation
University of KwaZulu-Natal (South Africa)
Sponsor details
The Chair
Bioethics Research Committee
Room N40
Govan Mbeki Building
Westville campus
Durban
3629
South Africa
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Hasso Plattner Ventures (Germany) - fund administered through the University of KwaZulu-Natal, for consumables
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
International Atomic Energy Agency (IAEA) (USA) - funded all equipment used in the study
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22192583
Publication citations
-
Results
Kindra G, Coutsoudis A, Esposito F, Effect of nutritional supplementation of breastfeeding HIV positive mothers on maternal and child health: findings from a randomized controlled clinical trial., BMC Public Health, 2011, 11, 946, doi: 10.1186/1471-2458-11-946.