Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
2017년 11월 20일 업데이트: Nazia Raja-Khan, Milton S. Hershey Medical Center
Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.
연구 개요
상세 설명
As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with PCOS. These adverse effects may ultimately increase the risk for serious long-term complications in PCOS, including type 2 diabetes and cardiovascular disease. The key objectives of this research study are to determine the effects of vitamin D supplementation on insulin resistance, inflammation, mood and overall well-being in women with PCOS.
The protocol has been modified by adding the following specific aim: To compare vascular function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. We are currently recruiting healthy women who are age and BMI similar to the PCOS women and measure their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular reactivity. These healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. They will not be enrolled in the placebo or Vitamin D randomization process as described above.
연구 유형
중재적
등록 (실제)
36
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033
- Penn State College of Medicine, Penn State Milton S Hershey Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
Diagnosis of PCOS based on:
- Eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and
- Elevated testosterone levels
Exclusion Criteria:
- Current Pregnancy or Nursing
- Elevated calcium
- Kidney Stones or kidney disease
- Current use of vitamin D (other than a multivitamin)
- Use of metformin or other insulin sensitizing drugs in the last 3 months
- Elevated prolactin or untreated thyroid disease
- Diabetes, Liver disease, Heart disease, or other serious medical condition
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
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Placebo by mouth once daily for 12 weeks
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실험적: 비타민 D
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Vitamin D 300 mcg by mouth once daily for 12 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
기간: Baseline and 12 weeks
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Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose.
Quantitative insulin sensitivity check index (QUICKI) = 1/[log(I(0)) + log(G(0))]).
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Baseline and 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
기간: Baseline and 12 weeks
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High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
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Baseline and 12 weeks
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Change From Baseline in Mean Systolic Blood Pressure
기간: Baseline and 12 weeks
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Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
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Baseline and 12 weeks
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Change From Baseline in Mean Diastolic Blood Pressure
기간: Baseline and 12 weeks
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Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
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Baseline and 12 weeks
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Change From Baseline in Mean Fasting Glucose
기간: Baseline and 12 weeks
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Glucose was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean Fasting Insulin
기간: Baseline and 12 weeks
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Insulin was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean 2-hour Glucose
기간: Baseline and 12 weeks
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Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
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Baseline and 12 weeks
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Change From Baseline in Mean 2-hour Insulin
기간: Baseline and 12 weeks
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Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
|
Baseline and 12 weeks
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Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
기간: Baseline and 12 weeks
|
Participants underwent a 75-g oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 120 minutes and used to calculate the insulin sensitivity index (ISI0,120).
The ISI 0,120 = the glucose uptake rate divided by the mean plasma glucose divided by the log(mean serum insulin).
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Baseline and 12 weeks
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Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
기간: Baseline and 12 weeks
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a validated measure of insulin resistance based on fasting insulin and glucose.
HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5.
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Baseline and 12 weeks
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Change From Baseline in Mean Total Cholesterol
기간: Baseline and 12 weeks
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Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean HDL Cholesterol
기간: Baseline and 12 weeks
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Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean LDL Cholesterol
기간: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
|
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Change From Baseline in Mean Triglycerides
기간: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean Total Testosterone
기간: Baseline and 12 weeks
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Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
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Baseline and 12 weeks
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Change From Baseline in Mean Free Testosterone
기간: Baseline and 12 weeks
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Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
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Baseline and 12 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Mean 25-hydroxyvitamin D
기간: Baseline and 12 weeks
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Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
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Baseline and 12 weeks
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Change From Baseline in Mean Vitamin D Binding Protein
기간: Baseline and 12 weeks
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Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
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Baseline and 12 weeks
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Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)
기간: Baseline and 12 weeks
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Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
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Baseline and 12 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Nazia Raja-Khan, M.D., Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 5월 1일
기본 완료 (실제)
2014년 2월 1일
연구 완료 (실제)
2014년 9월 1일
연구 등록 날짜
최초 제출
2009년 5월 21일
QC 기준을 충족하는 최초 제출
2009년 5월 21일
처음 게시됨 (추정)
2009년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 12월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 11월 20일
마지막으로 확인됨
2017년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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