1) Grant I_MURA 2018/02 Osteopenic woman Menopause Risk of fracture 2) Grant I_MURA 2018/90 Menopause Vulvovaginal Atrophy Osteopenia tocopherol Vitamin D Vitamin E Vulvovaginal Atrophy
Conditions
Interventions
mixed-tocopherol 400 mg,placebo
Placebo Comparator Drug,Placebo Comparator Drug
vitamin E 400 mg,placebo
Sponsors
Ramathibodi hospital, Mahidol university
Eligibility
Sex/Gender
Female
Age
45 Years to 100 Years
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grant I Research Outcome(1) is Bone turnover marker change(P1NP and CTX) at 12 week Level of P1NP and CTX (Continuous variable),Grant I Research Outcome(2)_Side Effects 12 weeks after intervention Event of side-effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Grant II Research Outcome(1)_ VMI(Vaginal maturation Index) at 0, 6 and 12 weeks Continuous VMI value,Grant II Research Outcome(2)_Vaginal PH, VAS of VVA symptoms at 0, 6 and 12 weeks continuous variables | — |
Countries
Thailand
Contacts
Public ContactKatanyuta Nakpalat
Faculty of medicine Ramathibodi hospital Mahidol university
Outcome results
None listed