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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.: PACTR201210000418271 Date registered: 2012/09/24
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
Purpose of the trial Prevention
Anticipated trial start date 2011-11-01
Actual trial start date 2011-11-30
Anticipated date of last follow up 2012-11-30
Actual date of last follow up
Anticipated target sample size (number of participants) 932   
Actual target sample size (number of participants) 932   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID
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

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group placebo daily orally 12-24 weeks up development of pre-eclampsia or delivery oral adminstration of placebo tablets 466 Placebo
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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 49 Years 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 2011/01/17 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 Fax
Principal Investigator Dr Paul Kiondo kiondop@yahoo.com +256 772 501 937
Street address City Postal code Country Position / Affiliation
Old Mulago Hill Kampala P.O. Box 7072 Uganda Senior Lecturer, Consultant Obstetrician & Gynaecologist
Role Name Email Phone Fax
Public Enquiries Prof Pius Okong mrokong@gmail.com +256 772 982 903
Street address City Postal code Country Position / Affiliation
Uganda Christian Univsity Mukono P.O. Box 4 Uganda Professor
Role Name Email Phone Fax
Scientific Enquiries Dr Paul Kiondo kiondop@yahoo.com +256 772 501 937
Street address City Postal code Country Position / Affiliation
Old Mulago Hill Kampala P.O. Box 7072 Uganda Senior Lecturer, Consultant Obstetrician & Gynaecologist