View clinical trials related to Vitamin D Deficiency.
Filter by:This is a human, II/b phase, multicentre, randomised, double blind, placebo-controlled study to assess the safety and the efficacy of a weekly administered dose of 30,000 IU vitamin D (colecalciferol) in deficient patients diagnosed with PCOS. Investigational products: 30.000 IU vitamin D or placebo administered once a week for 12-weeks-long period, followed by a 12-week-long open label treatment 30.000 IU vitamin D in a follow-up period. Each participant should be checked for regular dietary Ca intake and to assure the optimal calcium level the supplementation is provided with a commercially available Citrocalcium 200 mg tablets. Setting: I. Baseline and screening period: Baseline period considered as when the exogenous Vitamin D intake should not exceed the level of 1000 IU intake per day or a total 5000 NE per week dosages applied (in forms of any Vitamin D3 medication or multivitamin products) at least for 30 days prior the assessment made. II. Double-blind treatment period: Once a week per os applied Vitamin D or placebo treatment for 12 weeks according to randomisation of trial subjects in a 1:1 assignment. By the end of this period an interim assessment will be performed based on the analysis of primary efficacy parameters, stratification to responder and non-responder groups. III. Open label and follow-up phase: An open-label 30000 IU of Vitamin D treatment on weekly basis. (Vitamin D3 Pharma Patent 30000 IU tablets) for additional 12 weeks and continue with the follow-up assessments. A compassionate use of patient diary for additional 26 weeks. Objectives: Primary objectives: to assess the efficacy as a recovery of ovarian function based on progesterone levels and menses diary in at least 20% of trial subjects, compared to placebo treated group Secondary Objectives: assess the efficacy and safety of orally administered vitamin D treatment by the changes in 25(OH) D levels in PCOS patients. Explore the changes in Ovarian-morphology based on the results of standard TVUS Imaging: detection of adverse drug reactions during treatment periods, by frequency and distribution compared to follow-up periods and placebo group. Anticipated participants: 168
The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown. An observation study is currently being carried out by Ulster University and the Western Health & Social Care Trust (WHSCT) to provide data on the prevalence of vitamin-D deficiency among older adults within residential care facilities in NI. It is expected that some 40% of the cohort will be deficient in vitamin D and will require immediate replenishment of vitamin D status. Therefore, as a follow up to the observational study, an intervention study will be conducted, where participants identified as vitamin D deficient (25(OH)D) status <30nmol/L (cut-off currently used by the WHSCT will be re-contacted and provided with a vitamin D supplement. The aim of this study is to investigate the dose and duration of vitamin D supplementation that is required to replenish and maintain vitamin D status in older adults with vitamin D deficiency within residential care facilities. Participants will be randomly assigned to receive one of two supplementation regimes: 3200IU/day vitamin D3 or 20,000IU/week vitamin D3. Blood samples (no more than 20ml per appointment) will be taken at 4 different time points: week 0, week 2, week 4 and week 8. These two doses are routinely used in clinical practice for remedial supplementation of vitamin D and have been chosen based upon their availability from manufacturers of vitamin D supplements. Also, albeit these doses are currently routinely used to replenish vitamin D status little is known on how effective they are and how soon vitamin D status is optimised. Clinicians can only administer medication for the management of osteoporosis (e.g. bisphosphonates) once vitamin D status is optimised. Therefore, measurements will be taken every two weeks to establish response to the remedial supplementation. This project provides a unique opportunity to monitor the replenishment and maintenance of vitamin D status following remedial supplementation more regularly (at weeks 0,2,4,8) than would be done under standard National Health Service care. This does and duration of vitamin D required to replenish vitamin D deficiency in older adults is currently ambiguous within the literature and clinical care.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in reproductive age women, which causes disordered follicle growth and ovulation resulting in infertility. In addition women with PCOS have hyperandrogenemia and a dysregulated hormonal profile, resulting in altered feedback on the hypothalamic-pituitary-gonadal (HPG) axis. Obesity, insulin resistance, vitamin D (VD) deficiency and ageing worsen the symptoms. The gonadotrophins - follicle stimulating hormone (FSH) & luteinising hormone (LH), along with the pregnancy hormone human chorionic gonadotrophin (hCG) have structural similarities. The altered levels of FSH and LH in women with PCOS cause production of hCG from the brain leading to false positive pregnancy tests. Part one of this project will involve the investigation of this over-production of hCG in urine and serum of women with PCOS to develop suitable ovulation and pregnancy test kits, in collaboration with Swiss Precision Diagnostics (SPD). In Part two of the project, we would like to see if intervention with VD supplementation and/or using myo-inositol supplement compared with metformin (insulin sensitiser), improves prediabetes, distribution of fat/water content, weight loss and menstrual cyclicity in women with PCOS. We aim to correlate these interventions with particular serum & urine markers to develop better diagnostic tools.
Although vitamin D is known to play a major role in multiple organ functions in healthy adults, including bone homeostasis, its role in the unique population of orthopaedic polytrauma patients has not been well described. The aim of this therapeutic randomized placebo-controlled feasibility study is to determine the effect of vitamin D supplementation initiated on admission on patients' 25(OH)-D level, bone turnover markers, and clinical outcomes in a cohort of adult orthopaedic polytrauma patients. Polytrauma patients with one or more orthopaedic injuries admitted to an urban Level I trauma center will be screened for eligibility based upon strict inclusion and exclusion criteria. Sixty patients meeting the criteria will be consented, enrolled and randomized in a 1:1 ratio to intervention and control (placebo) arm. Baseline 25(OH)-D and bone turnover marker levels will be drawn for all the patients on admission, and the intervention arm will receive a one-time dose of ergocalciferol (Vitamin D2) 400,000 IU shortly after enrollment. The labs will be repeated 7 days after the initial draw or at discharge, whichever occurs first. Patients' daily immobilization status, baseline characteristics and clinical outcomes will be recorded. Statistical methods will be used to assess whether there is a difference in 25(OH)-D and bone turnover markers levels associated with the intervention.