Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201505001076143 Date of Approval: 17/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Moringa Oleifera and Nutriton oh HIV patients
Official scientific title IMPACT OF MORINGA OLEIFERA SUPPLEMENTATION ON BODY MASS INDEX AND IMMUNE RESPONSE OF HIV-PATIENTS UNDER ANTIRETROVIRAL THERAPY A SINGLE BLIND RANDOMIZED CLINICAL TRIAL
Brief summary describing the background and objectives of the trial Context and aims: compliance with the therapeutic regimen and a good immunometabolic response are indispensable factors for successful antiretroviral therapy (ART). Unfortunately, food insecurity is real impediment in this regard. In the DRC, a proportion of patients undergoing ART are affected by this and they are hence prone to therapeutic failure. In order to address this issue, some care facilities use Moringa Oleifera (M.O) powder to compensate for nutritional deficiencies. Aims: assessment of the impact of supplementation with M.O powder on the nutritional and immune status of people living with HIV(PLWHIV)and treated with antiretroviral, in general and according to their characteristics
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 15/03/2013
Actual trial start date 22/03/2013
Anticipated date of last follow up 25/09/2013
Actual Last follow-up date 15/10/2013
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
ESP/CE/005/2010
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation Allocation was determined by the holder (social worker) of the sequence who is situated off-site Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Moringa oleifera powder 30 g (10 g morning-noon-evening 6months Moringa oleifra powder from dried leaf. The subject were mixed this powder with the staple meals 30
Control Group counseling nutritonal Each Month 6 Months control group (CG) received nutritional counseling according to the food guidelines of the national program of nutrition in the DRC (PRONANUT). At each appointment in the social service 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
the patients included in the study had 18 years old above, treated with ART, at clinical stages 2 and 3 or 4 according to WHO classification but stabilied (without opportunisctic affection upon inclusion in the study). Without renal dysfunction, without adverse symptoms of malabsorption (digestive i.d without diarrhea in the three weeks preceding the beginning of study), and with a stable weight curve tree going months preceding the intervention study. were excluded from study pregnant women patients and patient who were in stages 1,2 ,3 and 4 but not stabilized, as welle as those who did attend not consent, or who did not attend the consultation. In addition to those with renal dysfunction. 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Ethics committee of the School for Public Health at the University of Kinshasa
Ethics Committee Address
Street address City Postal code Country
Université de Kinshasa Kinshasa KinXI Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome were changes in body mass index and biological parameters Body mass index were calculated monthly and the difference in body mass index between the 6th month and admission were calculated.
Primary Outcome Changes in biological parameters The biological parameters compared using blood tests pameters performed at inclusion of patients in the study and at 6th month. These parameters were: hemoglobin, albumin, creatinine, C-reactive protein, viral load, and CD4 lymphocytes
Secondary Outcome Changes in BMI according to chacteristiques of patients were the body mass index changes between the two study groups according to the characteristics socio demographic, socioeconomic, clinical and biological of the patients between the 6th month and admission
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ACS/AMOCONGO BONGANDANGA 82 C/KASA VUBU KINSHASA Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Fonds David & Alice Van Buuren Avenue Franklin Roosevelt 50 B-1050 Brussels 131/03 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Public Health School, Université Libre de Brussels Route de Lennik 808, Brussels 598 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Wilmet Michèle Dramaix Route de Lennik 808 B-1070 Brussels 598 Belgium
Philippe Donnen Route de Lennik 808 B-1070 Brussels 598 Belgium
Henri MUKUMBI Bongandanga 82 Kasa Vubu KINSHASA Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator KOY TSHINGANI tshingani.koy@ulb.ac.be 0032474730971 Route de Lennik 808
City Postal code Country Position/Affiliation
B-1070 Brussels 598 Belgium Research -PhD student
Role Name Email Phone Street address
Public Enquiries Mboma Bibi bimbo_tshi@yahoo.fr 0024385044288 15 Mbankana
City Postal code Country Position/Affiliation
Lemba, Q, Kemi, Kinshasa Kin IX Democratic Republic of the Congo
Role Name Email Phone Street address
Scientific Enquiries Wilmet Michèle Dramaix michele.dramaix@ulb.ac.be 0032-2-555.40.51 Route de Lennik 808
City Postal code Country Position/Affiliation
B-1070 Brussels 598 Belgium Professeur
REPORTING
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Result URL Hyperlinks
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