Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Primary outcome measure
Neonatal plasma vitamin C level after delivery and at 5 days postnatal age
Secondary outcome measures
Not provided at time of registration
Overall study start date
24/09/2002
Overall study end date
24/09/2005
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|