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)
| ISRCTN | ISRCTN04084517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04084517 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/01/2009
- Registration date
- 24/03/2009
- Last edited
- 24/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sandra Mutuma
Scientific
Scientific
Valid International/ Nutrition
Addis Abba Road/ Chaholi Road
Alex Masala Close
Plot 4126
Lusaka
P.O. Box 50719
Zambia
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | LRS (Lipid Research Study) |
| Study objectives | 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(s) | University of Zambia Biomedical Research Ethics Committee, approved on 20/11/2008 (ref: 009-10-08) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 26/01/2009 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 168 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/01/2009 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- Zambia
Study participating centre
Valid International/ Nutrition
Lusaka
P.O. Box 50719
Zambia
P.O. Box 50719
Zambia
Sponsor information
Valid International (UK)
Research organisation
Research organisation
35 Leopold St
Oxford
OX4 1TW
United Kingdom
| Website | http://www.validinternational.org |
|---|---|
"ROR" |
https://ror.org/00sb6vz77 |
Funders
Funder type
Research organisation
Valid international (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
