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NCT01141972 · ClinicalTrials.gov registry record · Phase 1
The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition
A Phase 1 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01141972: Completed Phase 1 study, sponsored by Kaiser Permanente.
NCT01141972 is a Phase 1 study that has completed, run by Kaiser Permanente. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01141972, a Phase 1 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
Vitamin D levels will be measured at baseline, after dose adjustments, and at the 3 month and final visit.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT01141972 record still lists
NCT01141972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01141972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01141972 about?
NCT01141972 is a clinical study titled "The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition". 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 ...
What is the current status of trial NCT01141972?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-09. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01141972?
The interventions under investigation include: Placebo (OTHER), Vitamin D (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01141972?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01141972's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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