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| [ ...Back to search results ] | [ Print-friendly version ] |
| MAternal VItamin D OSteoporosis Study |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN82927713 |
| Date ISRCTN assigned | 11/04/2008 |
| Local reference number(s) | 1.5 |
| Public title | MAternal VItamin D OSteoporosis Study |
| Scientific title | A randomised double-blind placebo-controlled trial of vitamin D supplements for pregnant women with low levels of vitamin D in early pregnancy |
| Acronym | MAVIDOS |
| Disease/condition/study domain | Osteoporosis |
| Study hypothesis | To test the hypothesis that vitamin D supplementation during pregnancy of women who have low levels of vitamin D will result in improved neonatal bone mineral content. This trial is carried out by the MRC Epidemiology Resource Centre (http://www.mrc.soton.ac.uk). |
| Design/methodology | Multi-centre randomised double-blind placebo controlled trial in two phases (pilot and main studies) |
| Research ethics review | Southampton and Southwest Hampshire Research Ethics Committee. Date of approval: 03/12/07 (ref: 07/H0502/113) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Less than 19 weeks gestation at first assessment (based on last menstrual period [LMP] and dating scan) 2. Serum 25(OH)-vitamin D concentration is 25-100 nmol/l at nuchal fold/ dating scan (10 to 19 weeks gestation) 3. Aged over 18 years 4. Singleton pregnancy 5. Aiming to give birth at local hospital |
| Participants - exclusion criteria | 1. Known metabolic bone disease 2. Current medication likely to interfere with intrauterine growth (corticosteroids, anticonvulsants, parathyroid hormone [PTH], bisphosphonates) 3. Foetal physical anomalies on the 12 week scan 4. Inability to provide informed consent or comply with trial protocol 5. History of renal stones, hyperparathyroidism, hypercalcuria 6. Measured hypercalacemia (>2.75mmol/l) 7. A diagnosis of cancer in the last 10 years 8. Cod liver oil of vitamin supplements containing vitamin D >200 iu per day 9. In-vitro fertilisation treatment |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/05/2008 |
| Anticipated end date | 01/05/2011 |
| Status of trial | Ongoing |
| Target number of participants | 1,074 |
| Interventions | This trial comprises pilot and main studies: Pilot study for the first 18 months, three groups of 60 participants each (total number of participants = 180): Group 1: 400 iu vitamin D3 (oral) per day, from 14 weeks gestation to delivery Group 2: 1,000 iu vitamin D3 (oral) per day, from 14 weeks gestation to delivery Group 3: Placebo, from 14 weeks gestation to delivery Main study will be vitamin D3 (dose chosen from pilot), from 14 weeks gestation to delivery vs placebo. 954 participants will be included in the main trial, 477 participants in each of the two arms (total number of participants = 954). The participants in the main trial vitamin D3 arm will include those who have participated in the pilot phase of the trial at the dose to be used in the main study i.e. 60 participants in the pilot study (either the 400 iu vitamin D3 or 1,000 iu vitamin D3 arm) will be included in the main study, and 894 new participants (954 - 60) will be recruited specifically for the main trial. |
| Primary outcome measure(s) | Neonatal whole body bone area, bone mineral content and bone mineral density assessed by dual energy x-ray absorptiometry (DXA) within 10 days of birth. |
| Secondary outcome measure(s) | 1. Neonatal and childhood anthropometry and body composition (weight, length and skinfold thickness measurements), assessed within 48 hours of birth 2. Women's attitude to pregnancy vitamin D supplementation (qualitative study; assessed in main study only). Methodology and timepoints of assessment not yet defined as of 03/03/2008 3. Childhood bone mass at 4 years |
| Sources of funding | Arthritis Research Campaign (ref: 17702) (UK) |
| Sponsor name | Southampton University Hospitals NHS Trust (UK) |
| Sponsor details | c/o Christine McGrath Southampton General Hospital Research and Development Office Southampton General Hospital Southampton United Kingdom SO16 6YD |
| Sponsor telephone | +44 (0)23 8079 4752 |
| Sponsor fax | +44 (0)23 8079 8678 |
| Sponsor email | christine.mcgrath@suht.swest.nhs.uk |
| Sponsor website | http://www.suht.nhs.uk |
| Contact name | Prof Cyrus Cooper |
| Contact details | Medical Research Council Epidemiology Resource Centre Southampton General Hospital Southampton United Kingdom SO16 6YD |
| Contact telephone | +44 (0)23 8077 7624 |
| Contact fax | +44 (0)23 8070 4021 |
| Contact email | cc@mrc.soton.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82927713 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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