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
Protocol serial number	N/A
Sponsor	University of KwaZulu-Natal (South Africa)
Funders	Hasso Plattner Ventures (Germany) - fund administered through the University of KwaZulu-Natal, for consumables, International Atomic Energy Agency (IAEA) (USA) - funded all equipment used in the study

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

Room 257, 2nd floor
DDMRI Building
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
Durban
4013
South Africa

Study information

Primary study design	Interventional
Study design	Prospective observational study with a nested randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	15/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes