The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition (FLASH)
Hot Flushes, Menopause, Premature, Obesity
About this trial
This is an interventional health services research trial for Hot Flushes focused on measuring Vitamin D, Obesity, Menopause, Hot Flashes
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Kaiser Permanente Center for Health Research
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Supplement
Placebo
We will administer 100,000 IU Vitamin D3 orally as an observed 1-time bolus and then prescribe 1000 IU by mouth daily. These doses have achieved sufficiency in other populations.99, 100 We will use the level of sufficiency (≥30 ng/ml [≥75 nmol/L]) that is recommended by most experts in the field.89-91, 93, 95, 96, 101-105 We will repeat the bolus at 1 month if the target level is not achieved. The control group will receive matching placebo and a similar proportion will go through a dummy titration. All women consuming less than 800 mg/day of calcium (by dietary history) will receive 500 mg of calcium to ensure sufficiency
Current standard of practice does not dictate that otherwise healthy early menopausal women have Vitamin D levels evaluated. Women with Vitamin D levels between 10 and 29 ng/ml who receive placebo will be receiving usual care (i.e., no additional Vitamin D repletion above intake at the time of screening).