| City: |
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Portland |
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State:
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OR |
| Zip Code: |
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97227 |
| Conditions: |
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Early Menopausal Symptoms - Obesity - Vitamin D Insufficiency |
| Purpose: |
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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.
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| Study summary: |
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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, cardiovascular disease, and cancer. We propose to explore if Vitamin D
replacement (safe, readily available, and inexpensive) has beneficial effects on 2 novel
outcomes in early postmenopausal women: menopause-related symptoms and body composition.
Most women transitioning through menopause, especially those with higher percent body fat,
will experience hot flashes through a mean of 4 to 5 years. Many also have mood disturbances
and muscle aches although the link with the menopausal transition is less clear. In many,
these symptoms are severe enough to negatively impact their quality of life, work
performance, and interpersonal relationships. Current treatments for menopause-related
symptoms, such as menopausal hormone therapy, antidepressants, and anticonvulsants, have
significant side effects and serious long term adverse consequences and symptoms recur after
treatment discontinuation. A safe, inexpensive, well-tolerated treatment is therefore of
high priority.
Both our preliminary data in early postmenopausal women and a 2010 publication of women on
aromatase inhibitors for breast cancer show an association between Vitamin D deficiency and
menopause-related symptoms including hot flashes. It is postulated that a contributor to hot
flashes is a menopausal decline in serotonin, a neurotransmitter with known effects on
thermoregulation. As Vitamin D can protect against experimental serotonin depletion in rats,
one proposed mechanism for symptom alleviation is prevention of serotonin decline in
menopause.
Both Vitamin D deficiency and the menopausal transition are associated with mood
disturbances and musculoskeletal aches. Because estrogen increases the activity of the
enzyme responsible for activating Vitamin D, the fall in estrogen that occurs during the
menopausal transition could uncover previously subclinical Vitamin D deficiency. Indeed,
Vitamin D can improved mood and muscle aches in non-menopausal populations, but its effects
in menopausal women, where the benefits may be magnified, have not been previously studied. |
| Criteria: |
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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 |
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| Study is available at: |
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Kaiser Permanente Center for Health Research
Portland, OR 97227
United States
Primary Contact:
Dan Laferriere, MSN
Email: Dan.Laferriere@kpchr.org
Phone: 503-335-6715 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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