Obesity Clinical Trial
— FLASHOfficial title:
The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition
Verified date | May 2012 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Center for Health Research | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | compare effects of Vitamin D supplementation to usual care on symptoms in women transitioning to early postmenopause and determine the associated effects | Vitamin D levels will be measured at baseline, after dose adjustments, and at the 3 month and final visit. | 12 months | No |
Secondary | 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 | Body composition will be measured with DXA113, 114 and anthropometric techniques (weight, height, BMI, waist to hip ratio) | 12 months | Yes |
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