Maternal vItamin D osteoporosis study

Not Applicable

Completed

• Conditions: Osteoporosis; Musculoskeletal Diseases; Osteoporosis without pathological fracture

• Registration Number: ISRCTN82927713
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

2012 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/22314083 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26944421 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27549309 results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30321476/ results (added 28/05/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34297067/ results (added 27/07/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36585903/ post hoc analysis (added 14/06/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35866154/ prespecified, 4-year follow up of offspring (added 14/06/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35763390/ risk of infantile atopic eczema (added 14/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-11
• Study Completion: 2016-12-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1074

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

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 (>2.75 mmol/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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eonatal whole body bone area, bone mineral content and bone mineral density assessed by dual energy x-ray absorptiometry (DXA) within 10 days of birth.