Status:
COMPLETED
The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Hot Flushes
Menopause, Premature
Eligibility:
FEMALE
40-60 years
Phase:
PHASE1
Brief Summary
Specific Aim 1: To compare effects of Vitamin D supplementation to usual care on symptoms in women transitioning to early postmenopause and determine the associated effect size in order to conduct a p...
Detailed Description
It is increasingly recognized that Vitamin D deficiency affects more than just bone health. Links between Vitamin D deficiency have been established or purported for diabetes, the metabolic syndrome, ...
Eligibility Criteria
Inclusion
- Women in late menopausal transition or early menopause
- Age 40-55
- BMI \>25 kg/m2
- Suffer from menopausal symptoms
- Change in previously regular cycles consisting of at least ≥2 skipped cycles and an interval of amenorrhea (≥60 days) in the last year
- Negative pregnancy test
- Vitamin D insufficiency (\<30 ng/ml)
- Weight stability (+/- 5%) for 3 months
Exclusion
- No period for \>12 months
- Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months
- History of hysterectomy more than 11 months ago
- Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine)
- History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis
- History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84
- Vitamin D deficiency (\<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will exclude \<2% of population)
- Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results)
- Current smoker (within the last year)
- Taking medications that affect body weight
- Prior bariatric surgery
- Taking medications or herbal supplements that affect mood (i.e. antidepressants) or menopausal symptoms (i.e. herbal meds) or sleep
- Weighing more than 400 pounds (cannot fit on DEXA scan)
- Not fluent in English or cognitively impaired
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01141972
Start Date
September 1 2010
End Date
February 1 2012
Last Update
May 30 2013
Active Locations (1)
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1
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227