Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Kaiser Permanente. The registered enrollment target is 23 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01141972
The ClinicalTrials.gov registry entry for NCT01141972 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01141972 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.