The effect of vitamin C and E supplementation in women with a history of two early pregnancy failures - a randomised controlled trial

ISRCTN ISRCTN61737241
DOI https://doi.org/10.1186/ISRCTN61737241
Secondary identifying numbers 03/0061
Submission date
29/04/2004
Registration date
04/06/2004
Last edited
27/11/2013
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eric Jauniaux
Scientific

Department of Obstetrics & Gynaecology
86-96 Chenies Mews
London
WC1E 6HX
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymAIM (Antioxidants in Miscarriage)
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMiscarriage
InterventionIntervention: Vitamin C 1000 mg and Vitamin E 400 IU
Control: Placebo

Updated 27/11/2013: the trial was stopped in October 2009 due to poor recruitment and lack of funding.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2000
Completion date31/05/2001
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaWomen with a history of two or more early pregnancy losses, with no identifiable cause for the losses
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2000
Date of final enrolment31/05/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Obstetrics & Gynaecology
London
WC1E 6HX
United Kingdom

Sponsor information

University College London Hospitals NHS Trust
Not defined

UCLH/UCL Research & Development Governance Committee
Research and Development Directorate
University College London Hospitals NHS Trust
1st Floor, Maple House
149 Tottenham Court Road
London
W1P 9LL
United Kingdom

ROR logo "ROR" https://ror.org/042fqyp44

Funders

Funder type

Hospital/treatment centre

The Early Pregnancy Research Fund (0125). University College London Hospital.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan