1.Effect of mixed-tocopherol supplement on Bone Turnover Markers in Postmenopausal Osteopenic Women: A prospective, double-blind randomized controlled trial 2.Effect of Vitamin D Supplement on Vulvovaginal Atrophy of the Menopause

Ramathibodi hospital, Mahidol university0 个研究点目标入组 52 人开始时间: 2018年4月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Grant I-MURA2018/02 (Vitamin E)
•Postmenopausal women with absent menstruation for at least one year, age over 45-year-old, osteopenia which bone mineral density measured by Dual-energy X-ray Absorptiometry T-score was between -1 and -2.5 at the lumbar spine, total hip or femoral neck, and signed the agreement to participate in the study, were included.
•-Grant II-MURA2018/90 (Vitamin D)
•Menopausal women, absence of menstruation for at least one year, a previous bilateral oophorectomy or serum FSH level more than 40 IU/L.
•Phase I : 1 February-15 May 2018, Prepare and inquire sites for conduct during wait for ethic approval. initial CRF based on proposal were reviewed by expert and research team.
•Phase II : After IRB approve (16 May 2018) : the initial CRF will send to sites or single site those enrolled to evaluate and collecting data after 16 May 2018 onward. During data collection if have any not understand CRF can contact back to research team via email.
•Phase III : We plan to finish of data collection aproximately May and not exeed 31 July 2019.

•-Grant I-MURA2018/02 (Vitamin E)
•Postmenopausal women were serum 25-hydroxyvitamin D (serum 25(OH)D level) < 20 ng/ml, having a history of metabolic bone disease, having a history of cancer, having an eating disorder or malabsorption, taking a medication that affects bone metabolism, taking an anticoagulant, currently taking a vitamin E supplement within 3 months and unwillingness to accept the randomization.
•-Grant II-MURA2018/90 (Vitamin D)
•Menopausal women were a history of hormonal treatments or vitamin D supplementation within the previous 12 weeks, abnormal PAP smear, active sexually transmitted
•disease, active urinary tract infection, abnormal uterine bleeding, or the presence of serious medical conditions, including cardiovascular disease, liver failure, and renal failure, patients with a history of vitamin D allergy or unwillingness to participate in the study protocol.

发起方

Ramathibodi hospital, Mahidol university