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02 September 2010
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| [ Print-friendly version ] |
| MAternal VItamin D OSteoporosis Study |
| ISRCTN | ISRCTN82927713 |
| ClinicalTrials.gov identifier | |
| 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 |
| Serial number at source | 1.5; 001-0002 |
| 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). |
| Ethics approval | Southampton and Southwest Hampshire Research Ethics Committee. Date of approval: 03/12/07 (ref: 07/H0502/113) |
| Study design | Multi-centre randomised double-blind placebo controlled trial in two phases (pilot and main studies) |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Osteoporosis |
| 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 |
| Anticipated start date | 01/05/2008 |
| Anticipated end date | 01/05/2011 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Trial website | |
| Publications | |
| Contact name | Prof Cyrus Cooper |
| Address |
Medical Research Council Epidemiology Resource Centre
Southampton General Hospital |
| City/town | Southampton |
| Zip/Postcode | SO16 6YD |
| Country | United Kingdom |
| Tel | +44 (0)23 8077 7624 |
| Fax | +44 (0)23 8070 4021 |
| cc@mrc.soton.ac.uk | |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Address |
c/o Christine McGrath
Southampton General Hospital Research and Development Office Southampton General Hospital |
| City/town | Southampton |
| Zip/Postcode | SO16 6YD |
| Country | United Kingdom |
| Tel | +44 (0)23 8079 4752 |
| Fax | +44 (0)23 8079 8678 |
| christine.mcgrath@suht.swest.nhs.uk | |
| Sponsor website: | http://www.suht.nhs.uk |
| Date applied | 25/02/2008 |
| Last edited | 19/11/2008 |
| Date ISRCTN assigned | 11/04/2008 |
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| © 2010 ISRCTN unless otherwise stated. | |
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