Effect of Vitamin E and Vitamin D supplement in Postmenopausal Wome

Phase 4

Completed

• Conditions: 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

• Registration Number: TCTR20180419001
• Lead Sponsor: Ramathibodi hospital, Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Study Completion: 2019-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 52

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

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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