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.: PACTR201210000418271 Date of Approval: 24/09/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vitamin C and pre-eclampsia
Official scientific title To evaluate the effects of vitamin C supplements on pre-eclampsia in Mulago hospital, Kampala, Uganda
Brief summary describing the background and objectives of the trial Background:Pre-eclampsia contributes significantly to maternal, fetal and neonatal morbidity and mortality. Oxidative stress plays a role in the aetiology of pre-eclampsia.It has been suggested that vitamin C supplements given to pregnant women may reduce pre-eclampsia. Objectives: To determine the effect of vitamin C supplements on i)risk of pre-eclampsia ii) preterm delivery iii)adverse fetal outcomes iv) adverse maternal outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Pre-eclampsia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2011
Actual trial start date 30/11/2011
Anticipated date of last follow up 30/11/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 932
Actual target sample size (number of participants) 932
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
2007-016 HS 1148
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 Permuted block randomisatio; block size 8 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 vitamin C tablets 1000 mg daily orally 12-24 weeks up development of pre-eclampsia or delivery oral adminstration of vitamin C tablets 466
Control Group placebo daily orally 12-24 weeks up development of pre-eclampsia or delivery oral adminstration of placebo tablets 466 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
pregnant women (primigravida or multigravida) gestational age 12-24 weeks age 15-49 years normal blood pressure lived 15 km or less from hospital willing to deliver at the hospital serious medical conditions e.g. sickle cell disease or cardiac disease taking vitamin C supplements >200mg/day had contraindications to vitamin C 15 Year(s) 49 Year(s) Female
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 17/01/2011 Makerere University School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old Mulago Hill Kampala P.O. Box 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pre-eclampsia antenatal period postnatal period
Secondary Outcome preterm delivery antenatal period delivery
Secondary Outcome adverse neonatal outcomes antenatal period delivery postnatal period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago hospital Old Mulago hill Kampala P.O. Box 7072 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Makerere University Makerere hill Kampala P.O. Box 7062 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University Makerere hill Kampala P.O. Box 7062 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Pius Okong Uganda Christan University Mukono P.O. Box 4 Uganda
Gabriel S Bimenya Makerere University College of Health Sciences Kampala P.O. Box 7072 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Kiondo kiondop@yahoo.com +256 772 501 937 Old Mulago Hill
City Postal code Country Position/Affiliation
Kampala P.O. Box 7072 Uganda Senior Lecturer, Consultant Obstetrician & Gynaecologist
Role Name Email Phone Street address
Public Enquiries Pius Okong mrokong@gmail.com +256 772 982 903 Uganda Christian Univsity
City Postal code Country Position/Affiliation
Mukono P.O. Box 4 Uganda Professor
Role Name Email Phone Street address
Scientific Enquiries Paul Kiondo kiondop@yahoo.com +256 772 501 937 Old Mulago Hill
City Postal code Country Position/Affiliation
Kampala P.O. Box 7072 Uganda Senior Lecturer, Consultant Obstetrician & Gynaecologist
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