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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68128332

Enrollment

192

Registered

2011-02-07

Start date

2006-11-20

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus (HIV)

Interventions

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 maln

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026