The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition
Completed · Phase 1 · Has a placebo group
Conditions studied: Hot Flushes, Menopause, Premature, Obesity, Vitamin D Deficiency
In brief
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 power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in early postmenopause who are randomized to supplementation, titrated to achieve sufficiency for 2 months, will have fewer symptoms including hot flashes, mood, and musculoskeletal complaints than women randomized to usual care. Specific Aim 2: To compare effects of Vitamin D supplementation to usual care on body composition (by dual-energy x-ray absorptiometry \[DXA\] and by weight, BMI, waist to hip ratio) in overweight/obese women transitioning to early postmenopause and determine the associated effect size for a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in the menopausal transition randomized to supplementation, titrated to achieve sufficiency for 9 months, will improve DXA body composition (less total body and abdominal fat), compared to women in usual care, who will have increased body weight, including total and abdominal fat. Specific Aim 3: To estimate the proportion of overweight/obese middle-aged women who achieve sufficiency by 1 month versus 2 or more months and to determine if achieving sufficiency by 1 month varies by baseline characteristics. Hypothesis: About 80% of participants will achieve sufficient Vitamin D level by 1 month. Those who need more than 1 month for sufficiency will have lower baseline levels and higher initial BMI.
Key facts
- Study ID
- NCT01141972
- Run by
- Kaiser Permanente
- People needed
- 23
- Starts
- 2010-09-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2013-05-30
Who can join
Age: 40 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kaiser Permanente Center for Health Research — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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