Condition category
Infections and Infestations
Date applied
19/01/2011
Date assigned
07/02/2011
Last edited
06/06/2012
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

Dr Gurpreet Kindra

ORCID ID

Contact details

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

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

http://research.ukzn.ac.za/

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

  1. 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.

Additional files

Editorial Notes