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.: PACTR201811722056449 Date of Approval: 13/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title MORINGA OLEIFERA AS A NUTRITIONAL SUPPLEMENT ON HIV PATIENTS ON ANTIRETROVIRAL THERAPY IN NIGERIA
Official scientific title EVALUATION OF THE ADDITION OF MORINGA OLEIFERA AS A NUTRITIONAL SUPPLEMENT ON THE ANTHROPOMETRIC, VIRAL LOAD AND CD4 COUNTS OF HIV PATIENTS ON ANTIRETROVIRAL THERAPY IN NIGERIA
Brief summary describing the background and objectives of the trial The aim of the study is to evaluate the effect of Moringa oleifera supplementation on the nutritional development (anthropometric parameters) and immunological development (viral load, CD4 counts and frequency of HIV co-morbid infections/conditions and HIV- related disease) of HIV positive adults on antiretroviral therapy. The study will further assess the impact of Moringa oleifera supplementation on quality of life (QoL) in patients with HIV and AIDS on ART drugs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MONSART
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 04/09/2017
Actual trial start date 04/12/2017
Anticipated date of last follow up 18/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 172
Actual target sample size (number of participants) 200
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Moringa Oleifera Leaves powder 5g three times daily Six months Moringa powder is made from naturally- dried moringa leaves. It is green in colour and has a flavour similar to spinach. 100
Control Group Coloured Corn starch powder 5g three times daily Six months Coloured corn starch powder is made by colouring corn starch powder with moss green food grade colour to look similar in colour and appearance to moringa leaves powder. 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Being HIV sero-positive 2. Patients ≥ 18 years old 3. Patients with CD4 counts ≤ 500 cells/mm3 4. Commenced ART at least for three months (Tenofovir + Lamivudine + Efavirenz combination). 5. Be willing to give informed consent and comply with study protocol 1. Known allergy or intolerance to Moringa oleifera or placebo (cornstarch powder) 2. Pregnant women 3. Patients with CD4 counts > 500 cells/mm3 4. Patients with active opportunistic infection 5. Patients taking anti-coagulant, micronutrient or natural health product supplements within 30days of randomization 6. Patients with poor or suboptimal adherence to ART medication 7. For ease of monitoring and to achieve maximum compliance to study protocol, patients living outside Kano metropolis will be excluded. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 23/05/2017 BREC
Ethics Committee Address
Street address City Postal code Country
Westville campus, Govan Mbeki Building Durban 4000 South Africa
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 24/07/2017 AKTH
Ethics Committee Address
Street address City Postal code Country
Zaria Road Kano 700233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in immunological status: a. CD4 Baseline and at the end of each month
Primary Outcome Change in immunological status: b. Viral load Baseline and at the end of study
Primary Outcome Change in anthropometric parameters ( weight, BMI, waist-hip circumference & mid-arm circumference) Baseline and at the end of each month
Primary Outcome Occurrence and frequency of opportunistic infections At the end of each month
Secondary Outcome Patients’ quality of life (QoL) Baseline and at the end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Zaria Road Kano 700233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
College of Health Science PhD Scholarship Mazisi Kunene Road, Glenwood Durban 4041 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UKZN 2nd Floor, George Campbell Building, Rick Turner Road, Gleenwood Durban 4041 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aisha Gambo gamboaishatu@yahoo.com +2340835392408 Dr Bala Muhammad Road
City Postal code Country Position/Affiliation
Kano 700222 Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries Indres Moodley Moodleyi15@ac.za +27837041948 Rick Turner Road, Glenwood
City Postal code Country Position/Affiliation
Durban 4041 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Musa Babashani babashanim@yahoo.com +2348037866247 Zaria Road
City Postal code Country Position/Affiliation
Kano 700233 Nigeria Onsite supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information