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: www.pactr.org
Trial no.: PACTR2009110001673419 Date of Approval: 25/11/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PREDINAM
Official scientific title TBscore (and suPAR) used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial
Brief summary describing the background and objectives of the trial It is hypothesised that food supplementation for pulmonary TB will lower mortality although the evidence hitherto is inconclusive. Thus further, well powered studies are needed to collect evidence that food supplementation is beneficial for patients suspected of having TB. We aim to identify the prevalence of malnutrition in pulmonary TB suspects, pulmonary TB patients, and healthy controls and to evaluate the use of a standardized nutritional support to lower mortality in PTB suspects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PREDINAM
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 13/05/2014
Actual trial start date 13/05/2014
Anticipated date of last follow up 12/06/2015
Actual Last follow-up date 15/06/2015
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Ulandsprojekt Sagsnr. 1400352 Den Centrale Videnskabsetiske Komité (CVK)
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
Randomised Simple randomisation using a radomisation table created by a computer software program. Patients select a closed enveloped with a number, which then is found on the randomisation table. Sealed opaque envelopes. Open-label(Masking Not Used)
Randomised Simple randomisation using a radomisation table created by a computer software program. Patients select a closed enveloped with a number, which then is found on the randomisation table. Sealed opaque envelopes. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group AFYA biscuits - nutritional supplementation (TBsuspects) 3 biscuits a day. 30 days 200
Control Group Normal treatment (TB suspects) Patients in this group will be treated according to the decision of the consulting doctor at the health center. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- adults (> 15 years) - At least one symptom indicating possible TB: 3 weeks of cough, sputum production or weight loss. - Residents or long-term guests of Bandim I, Bandim II, Belem, Mindara and Cuntum. None 15 Year(s) 100 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 08/02/2010 Comite Nacional de Etica na Saude
Ethics Committee Address
Street address City Postal code Country
Instituto Nacional de Saude Publica. Avenida Combatente da Liberdade de Pacitria, Hospital "3 de Agosto". Apartado: 861 Bissau Bissau Codex 1004 Guinea-Bisseu
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 04/03/2014 The national comittee on health research ethics, Denmark
Ethics Committee Address
Street address City Postal code Country
holbergsgade 6 Copenhagen 1057 Denmark
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome gain in BMI after 1 month
Secondary Outcome all-cause mortality 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centro de Saude, Cuntum Cuntum, Bissau Guinea-Bisseu
Centro de Saude, Bandim Bandim Guinea-Bisseu
Centro de Saude, Belem Bissau Guinea-Bisseu
FUNDING SOURCES
Name of source Street address City Postal code Country
Klinisk Forskningscenter Hvidovre København Denmark
Klinisk Forskningscenter Hvidovre København Denmark
Århus Universitets Forskningsfond Århus 8200 Denmark
Århus Universitets Forskningsfond Århus 8200 Denmark
EDCTP 300 Laan van Nieuw Oost Indië The Hague 2509 AA Netherlands
EDCTP 300 Laan van Nieuw Oost Indië The Hague 2509 AA Netherlands
A P Møller fonden (lægev. Fremme) Esplanaden 50 København K 1098 Denmark
A P Møller fonden (lægev. Fremme) Esplanaden 50 København K 1098 Denmark
Frimodt-Heineke Fonden Edelslundsvej 1A, 2.tv Klampenborg 2930 Denmark
Frimodt-Heineke Fonden Edelslundsvej 1A, 2.tv Klampenborg 2930 Denmark
Jacob og Olga Madsen Fond Nørre voldgade 88 København K 1359 Denmark
Jacob og Olga Madsen Fond Nørre voldgade 88 København K 1359 Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Christian Wejse Center for Global Health, School of Public Health Aarhus University, Bartholins Alle 2 Aarhus C 8000 Denmark University
Primary Sponsor Christian Wejse Center for Global Health, School of Public Health Aarhus University, Bartholins Alle 2 Aarhus C 8000 Denmark University
Secondary Sponsor Cecilie Blenstrup Patsche Apartado 861 Bissau Guinea-Bisseu University
COLLABORATORS
Name Street address City Postal code Country
Victor Gomes Apartado 861 Bissau Guinea-Bisseu
Peter Aaby Apartado 861 Bissau Guinea-Bisseu
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frauke Rudolf frauke.rudolf@ki.au.dk +45 51372359 Bakkedraget 2a, 1. tv
City Postal code Country Position/Affiliation
Hillerød 3400 Denmark MD PhD
Role Name Email Phone Street address
Public Enquiries Frauke Rudolf frauke.rudolf@ki.au.dk +45 51372359 Bakkedraget 2a, 1. tv
City Postal code Country Position/Affiliation
Hillerød 3400 Denmark MD PhD
Role Name Email Phone Street address
Scientific Enquiries Christian Wejse wejse@dadlnet.dk Phone: +45-89498492 Department of infectious diseases Skejby sygehus, Aarhus University Hospital Brendstrupgårdsvej
City Postal code Country Position/Affiliation
Århus N 8200 Denmark PhD/Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/05/2014 changed data 169
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/05/2014 Predicted sample size 169 400
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 13/05/2014 Since the effect of the AFYA-biscuits is unknown, it was decided to randomize to either biscuits or nothing. Parallel: different groups receive different interventions at same time during study Single group: all participants receive same intervention throughout study
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 13/05/2014 Further clarified. Simple randomisation using a radomisation table created by a computer software program Simple randomisation using a radomisation table created by a computer software program. Patients select a closed enveloped with a number, which then is found on the randomisation table.
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 13/05/2014 changed due to the new, approved protocol in which this trial is incorporated. true true
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 13/04/2010 Modified CCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 19/07/2010 Modified Not yet recruiting Temporary halt or suspension
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/05/2014 changed information 400
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 13/05/2014 Has been the original primary sponsor, but was not added due to a mistake earlier. Primary Sponsor Primary Sponsor
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/05/2014 changed data
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/05/2014 changed data 169
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 13/05/2014 Is one of the primary sponsor, lost in the previous revision of the registry. Primary Sponsor Primary Sponsor
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 19/07/2010 Modified CCT CCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/05/2014 Actual sample size not known yet 169
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 13/04/2010
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 13/05/2014 The trial was part of a earlier protocol, which was completed in 2013. However, the trial was incorporated in another protocol,with focus on nutritional status among TB suspects and patients and healthy controls. We hypothesize that in a limited-resource-setting with , it is possible to reduce mortality in TB and aTBneg (assumed TB negative) patients by focussing on patients needing most attention. Our objective is to reduce mortality among individuals with symptoms of TB infection using simple tools (TBscore and suPAR)to provide individualized treatment. If TB mortality can be reduced with simple measures available in high burden settings, this will be a major step forward in the battle against TB. It is hypothesised that food supplementation for pulmonary TB will lower mortality although the evidence hitherto is inconclusive. Thus further, well powered studies are needed to collect evidence that food supplementation is beneficial for patients suspected of having TB. We aim to identify the prevalence of malnutrition in pulmonary TB suspects, pulmonary TB patients, and healthy controls and to evaluate the use of a standardized nutritional support to lower mortality in PTB suspects.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 13/05/2014 changed due to the new, approved protocol in which this trial is incorporated. 400
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 13/04/2010 Modified Not yet recruiting Not yet recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 13/05/2014 Modified Temporary halt or suspension Open to recruitment: actively recruiting participants
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 13/05/2014 3 weeks of cough changed to current cough, since we have previously shown, that 1/3 of all smear positive TB-patients are lost if cough>3 weeks is applied. - adults (> 15 years) - At least one symptom indicating possible TB: 3 weeks of cough, sputum production or weight loss. - Residents or long-term guests of Bandim I, Bandim II, Belem, Mindara and Cuntum. - adults (> 15 years) - At least one symptom indicating possible TB: current cough, sputum production or weight loss. - Residents or long-term guests of Bandim I, Bandim II, Belem, Mindara and Cuntum.
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 13/05/2014 New protocol true true
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 13/05/2014 The trial has been incorporated into another protocol, where suPAR is not included. TBscore and suPAR used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial TBscore (and suPAR) used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 13/05/2014 The trial was part of a earlier protocol, which was completed in 2013. However, the trial was incorporated in another protocol, where suPAR was not included. TBscore and suPAR used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial TBscore (and suPAR) used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 29/11/2011 Modified RCT RCT
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 13/04/2010 Open-label (masking not used) Open-label (masking not used)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 13/05/2014 The trial has been incorporated into another protocol. We hypothesize that in a limited-resource-setting with , it is possible to reduce mortality in TB and aTBneg (assumed TB negative) patients by focussing on patients needing most attention. Our objective is to reduce mortality among individuals with symptoms of TB infection using simple tools (TBscore and suPAR)to provide individualized treatment. If TB mortality can be reduced with simple measures available in high burden settings, this will be a major step forward in the battle against TB. It is hypothesised that food supplementation for pulmonary TB will lower mortality although the evidence hitherto is inconclusive. Thus further, well powered studies are needed to collect evidence that food supplementation is beneficial for patients suspected of having TB. We aim to identify the prevalence of malnutrition in pulmonary TB suspects, pulmonary TB patients, and healthy controls and to evaluate the use of a standardized nutritional support to lower mortality in PTB suspects.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 13/05/2014 changed due to the new, approved protocol in which this trial is incorporated. 2014-05-13
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 13/05/2014 According to the new protocol. None The subject may withdraw at will at any time. The subject may be withdrawn from the trial at the discretion of the Sponsor¿Investigator if judged noncompliant with trial procedures. There are no known side effects to AFYA¿. However, should a participant develop allergic symptoms (rash, trouble of breathing or flushing) he/she is advised to contact the responsible field assistant. All participating patients are informed about allergic symptoms and are supplied with a contact telephone number. In addition, a subject must be withdrawn if the following applies: ¿ Moving outside of study area to a place unreachable for follow¿up. The observation time until moving will be used.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 19/07/2010 Modified CCT RCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 13/05/2014 changed due to the new, approved protocol in which this trial is incorporated. 2015-06-12
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 09/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 09/07/2018 pactr update Nutritional, Metabolic, Endocrine
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 09/07/2018 update 15 Jun 2015