Condition category
Infections and Infestations
Date applied
20/01/2009
Date assigned
24/03/2009
Last edited
24/03/2009
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 Sandra Mutuma

ORCID ID

Contact details

Valid International/ Nutrition
Addis Abba Road/ Chaholi Road
Alex Masala Close
Plot 4126
Lusaka
P.O. Box 50719
Zambia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled study assessing the effect of nutritional intervention with ready to use therapeutic food (RUTF) on blood lipid profiles of moderate to severely malnourished adults receiving antiretroviral therapy (ART) in Lusaka, Zambia

Acronym

LRS (Lipid Research Study)

Study hypothesis

The use of high fat energy dense ready to use therapeutic food in HIV positive malnourished adults receiving antiretroviral therapy (ART) does not produce deleterious changes in their blood lipid profiles.

Ethics approval

University of Zambia Biomedical Research Ethics Committee, approved on 20/11/2008 (ref: 009-10-08)

Study design

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

HIV and malnutrition

Intervention

Participants will be randomly allocated to the following two arms:

Intervention group: Participants will receive 2 jars/day of RUTF for 3 months, each jar weighs 250g (for 100g RUTF: energy content = 530 kcal, of which 47-59% are from oil and 10% are protein calories) in addition to prescribed ART regimen, nutritional advice and counselling.

Control group: Participants will receive ART, nutritional advice and counselling only

Total duration of interventions: 3 months

This trial will initially be a single-centre trial but may be extended to be a two-centre trial depending on recruitment rates.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total cholesterol/high density lipoprotein cholesterol (TC/HDL-C) ratio (TC/HDL-c ratio >= 5), assessed at baseline, Month 3, 6, 9 and 12 after enrolment into the study.

Secondary outcome measures

The following will be assessed at baseline, Month 3, 6, 9 and 12 after enrolment into the study:

1. Lipid profile:
1.1. Mean change in total cholesterol (TC)
1.2. Mean change in high density lipoprotein cholesterol (HDL-c)
1.3. Mean change in low density lipoprotein cholesterol (LDL-c)
1.4. Mean change in total triglycerides (TG)

2. Body composition:
The endpoints will be the correlation between change in TC and in:
2.1. Body fat mass proportion
2.2. Fat free mass (FFM) proportion
2.3. Fat-free mass index (FFMI) which controls for height

3. Nutritional status:
The endpoints will be the correlation between change in TC and in:
3.1. Weight (kg)
3.2. MUAC (mm)
3.3. BMI (kg/m^2)
3.4. Waist circumference

Note: Some of the secondary endpoints (e.g., weight, MUAC, waist measurements) may be taken at two weekly intervals from baseline up to Month 3 as well as at the timepoints indicated above.

Overall trial start date

26/01/2009

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Eligible for ART or has started ART within last 2 weeks
2. Both males and females, age >=18 years to <=49 years
3. mid-upper arm circumference (MUAC) <22.0 cm
4. Body mass index (BMI) <17.0 kg/m^2
5. CD4 Count >50
6. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

168

Participant exclusion criteria

1. Pre-existing diabetes
2. History of cardiovascular disease (CVD) including hypercholestrolaemia, hypertension
3. On other medications that may have an effect on blood lipid profiles (besides routine HIV prophylaxis and tuberculosis [TB] treatment)
4. CD4 count <50
5. Unable to tolerate solid foods
6. Failed appetite test
7. Subjects with pacemakers or any implantable electronic devices
8. Pregnancy or lactation
9. Psychiatric illness
10. Nut allergies
11. Consent declined
12. Any other reason why the consenting investigator thinks it is not appropriate for them to take part

Recruitment start date

26/01/2009

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Zambia

Trial participating centre

Valid International/ Nutrition
Lusaka
P.O. Box 50719
Zambia

Sponsor information

Organisation

Valid International (UK)

Sponsor details

35 Leopold St
Oxford
OX4 1TW
United Kingdom

Sponsor type

Research organisation

Website

http://www.validinternational.org

Funders

Funder type

Research organisation

Funder name

Valid international (UK)

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

Publication citations

Additional files

Editorial Notes