The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition

NCT01141972 | Completed Phase 1

• 1 other identifier: Pro00001445
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hot Flushes; Menopause, Premature; Obesity; Vitamin D Deficiency

Keywords

Vitamin D; Obesity; Menopause; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

  12 months

Study Arms (2)

Supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

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.

Supplement

Placebo OTHER

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).

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Hot Flashes; Menopause, Premature; Obesity; Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Avitaminosis; Deficiency Diseases; Malnutrition

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Erin S. LeBlanc, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 11, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 30, 2013

Record last verified: 2012-05

Locations

US (1)