Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr PA Clarke

ORCID ID

Contact details

Neonatal ICU
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0217117009

Study information

Scientific title

Acronym

Study hypothesis

To determine whether maternal vitamin C supplementation prior to preterm delivery results in:
1. Higher maternal plasma vitamin C level at the time of delivery
2. Higher vitamin C levels in preterm infants at birth and at 5 days postnatal age

Ethics approval

Not provided at time of registration

Study design

Double blinded prospective randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Neonatal Diseases: Vitamin supplementation

Intervention

Vitamin C vs placebo

Added 15/07/09: the trial never started.

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin C

Primary outcome measures

Neonatal plasma vitamin C level after delivery and at 5 days postnatal age

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/09/2002

Overall trial end date

24/09/2005

Reason abandoned

Lack of funding/sponsorship + Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

Pregnant women admitted to Hope Hospital antenatally who are at high risk of premature delivery before 35 weeks gestation.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion critera.

Recruitment start date

24/09/2002

Recruitment end date

24/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatal ICU
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Salford Royal Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes