A randomised double-blind placebo-controlled trial of vitamin D supplements for pregnant women with low levels of vitamin D in early pregnancy

Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 1,074 人开始时间: 2008年4月11日最近更新: 2023年6月26日

适应症

试验速览

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)

•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

•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

发起方

Southampton University Hospitals NHS Trust (UK)