Effect of maternal vitamin C supplementation on plasma vitamin C levels in preterm infants during the early neonatal period
| ISRCTN | ISRCTN18855042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18855042 |
| Protocol serial number | N0217117009 |
| Sponsor | Department of Health (UK) |
| Funder | Salford Royal Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 15/07/2009
- 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
Dr PA Clarke
Scientific
Scientific
Neonatal ICU
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blinded prospective randomised placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Vitamin supplementation |
| Intervention | Vitamin C vs placebo Added 15/07/09: the trial never started. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Neonatal plasma vitamin C level after delivery and at 5 days postnatal age |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 24/09/2005 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship + Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key inclusion criteria | Pregnant women admitted to Hope Hospital antenatally who are at high risk of premature delivery before 35 weeks gestation. |
| Key exclusion criteria | Does not match inclusion critera. |
| Date of first enrolment | 24/09/2002 |
| Date of final enrolment | 24/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Neonatal ICU
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
