A randomised double-blind placebo-controlled trial of vitamin D supplements for pregnant women with low levels of vitamin D in early pregnancy
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- Southampton University Hospitals NHS Trust (UK)
- Enrollment
- 1074
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified