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.: PACTR202201495929140 Date of Approval: 25/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nutritional supplementation and HIV/AIDS in Chad
Official scientific title Effects of daily supplementation with spirulina fortified cereals on the nutritional status and treatment outcomes of people living with HIV/AIDS in Chad
Brief summary describing the background and objectives of the trial The nutritional status of people living with HIV/AIDS (PLHA) in low and middle income countries (LMIC) remains a major determinant of mortality, a lower response to the antiretroviral treatment (ART) and a higher dropout rate from ART. Poor nutritional status is common among PLHA in LMIC. It results in wasting and micronutrient deficiencies which increase the risk of morbidity in a weakened immune response. Adults infected with HIV have their energy requirements increased by 10%; and this increase may reach 20-30% when they are symptomatic (WHO, 2003). Poor nutritional status of PLHA is essentially a result of 1) poor dietary practices, 2) nutrient malabsorption, and 3) recurrent infections. Nutritional care of PLHA when combined with ART improves food security of the already vulnerable population and might enhance the response to treatment by improving the nutritional status of PLHA. In Chad, the National Council for the fight against AIDS estimated that in 2014-2015 there were 206,467 PLHA (1.6% of the population). Among these people, slightly less than half needed an ART. Since 2007, the medical care of PLHA was guaranteed by the Ministry of Health who provided the ART gratis in the whole country. However the lack of nutritional care of PLHA remains a serious problem that limits the progress in improving the quality of life among PLHA. Spirulina (Spirulina platensis) is a blue-green algae that is promoted as a dietary supplement because it is rich source of high quality macro- and micronutrients. There is a limited number of studies available assessing the effectiveness of spirulina supplementation in the nutritional care of PLHA. The study aims to assess -among PLHA receiving ART- the effectiveness of nutritional care of PLHA, i.e. supplementation with fortified or unfortified millet flour with spirulina, on their nutritional status and response to ART compared to PLHA who just started ART but receive standard care without supplementations.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AIDSChad
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/06/2018
Actual trial start date 01/06/2018
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date 31/03/2020
Anticipated target sample size (number of participants) 345
Actual target sample size (number of participants) 345
Recruitment status Completed
Publication URL https://www.ugent.be/ge/phpc/en/research/units/public-health-nutrition-projects
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care No supplementation 6 months Participants received only the standard care (ART and nutritional counseling) 115 Active-Treatment of Control Group
Experimental Group Positive control 500 g of millet flour daily (250 g in the morning and 250 g in the evening) 6 months Participants received millet flour daily for six months in addition to the standard medical care. 115
Experimental Group Intervention group 500 g of spirulina-fortified flour daily (250 g in the morning and 250 g in the evening). 6 months Participants received millet flour fortified with spirulina in addition to the standard medical care. 115
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Informed and signed consent 2- Diagnosed HIV-positive and recently started ARV treatment 3- Age between 18 to 45 years. 4- Permanent resident in N’Djamena and receiving medical care at the N’Djamena Day Hospital, Chad and from AL-NADJMA Center for Psycho-Medico-Social Support (APMS), Ndjamena, Chad 5- No other chronic diseases (Tuberculosis, Cardiovascular disease etc.), 1- Patient benefiting from a food and / or nutritional supplementation program 2- Patient who already receives regularly spirulina in their diet 4- Participants allergic to spirulina and other hyper protein products; 6- Pregnant and lactating women Adult: 19 Year-44 Year 18 Year(s) 45 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 11/05/2017 Ministry of Health and Population
Ethics Committee Address
Street address City Postal code Country
Djari Ndjamena BP440 Chad
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body weight At baseline and at endline
Primary Outcome Lean mass accretion At baseline and at endline
Secondary Outcome Viral load Baseline and endline
Secondary Outcome CD4 Baseline and endline
Secondary Outcome Biochemical indicators including hemoglobin concentration; complete blood count (CBC); creatinine; urea; transaminase; and blood sugar Baseline and endline
Secondary Outcome Adherence to ART Monthly from baseline until endline
Secondary Outcome Comorbidities including malaria, respiratory diseases, diarrhea and other infectious diseases Monthly from baseline to endline
Secondary Outcome Knowledge, attitude and practices KAP Baseline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Psycho Medico Social Support Center Rond Point Hamama. Ndjamena 440 Chad
FUNDING SOURCES
Name of source Street address City Postal code Country
The International Atomic Energy Agency IAEA Vienna International Centre Vienna 1400 Austria
Department Public Health and Primary Care of the University of Ghent Campus UZ Gent, Corneel Heymanslaan 10 Entrance 42 Ghent 9000 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stefaan De Henauw Campus UZ Gent, Corneel Heymanslaan 10, Entrance 42 Ghent 9000 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Souheila Abbeddou Campus UZ Gent, Corneel Heymanslaan 10 Ghent 9000 Belgium
Dimanche Sansan Rue 5609 NDjamena 450 Chad
Alain Nahaskida Avenue Mobutu NDjamena 480 Chad
Abdelsalam Tidjani Rue Bololo NDjamena 1117 Chad
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alain Nahaskida alain_nahaskida@yahoo.fr +23566346917 Avenue Mobutu
City Postal code Country Position/Affiliation
NDjamena 480 Chad Researcher at Ministry of Public Health and Solidarity of Chad.
Role Name Email Phone Street address
Scientific Enquiries Souheila Abbeddou Souheila.Abbeddou@UGent.Be +32467630892 Campus UZ Gent, Corneel Heymanslaan 10, Entrance 42
City Postal code Country Position/Affiliation
Ghent 9000 Belgium Senior Postdoctoral researcher
Role Name Email Phone Street address
Public Enquiries Stefaan De Henauw Stefaan.DeHenauw@UGent.be +3293323679 Campus UZ Gent, Corneel Heymanslaan 10, Entrance 42
City Postal code Country Position/Affiliation
Ghent 9000 Belgium Unit head of the Public Health Nutrition group
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be compiled, pseudonymized and provided a repository. A repository has not been defined yet but the team is aiming to create it at the Open Science Framework (OSF) Informed Consent Form,Statistical Analysis Plan,Study Protocol 1- Will individual participant data be available (including data dictionaries? Yes 2- What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification (names and addresses, data of birth and sex will be removed). Data that is going to be compiled include anthropometric measurements, adherence, biochemical and clinal data and socioeconomic characteristics. 3- What other documents will be available? Study protocol, Statistical Analysis Plan, Informed Consent Form. 4- What will data be available ( Start and End dates) Immediately following publications and will remain open. 5- With whom? With the PI, Mr. Alain Nahaskida and the collaborator Dr. Souheila Abbeddou. Later it will at the OSF 6- For what types of analyses? Secondary et metanalyses 7- By what mechanism will data be made available? Data are available indefinitely at OSF (repository has not been created as yet). Access to IPD will be controlled by two collaborators of the project, Mr. Alain Nahaskida and Dr. Souheila Abbeddou. Access will be given after a request is sent and the response will be given as soon as possible. Access will be given tp academics and organizations whose aim is either to conduct metanalyses or cross-site analyses to inform policies which aim to improve the lives of people living with HIV/AIDS in low income settings. Additionally, access will be given to food industry partners who aim to invest in the same field of industrial food fortification.
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