- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00907153
Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Места учебы
-
-
Pennsylvania
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Hershey, Pennsylvania, Соединенные Штаты, 17033
- Penn State College of Medicine, Penn State Milton S Hershey Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Плацебо Компаратор: Плацебо
|
Placebo by mouth once daily for 12 weeks
|
Экспериментальный: Витамин Д
|
Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
Временное ограничение: Baseline and 12 weeks
|
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))]).
|
Baseline and 12 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
Временное ограничение: Baseline and 12 weeks
|
High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Systolic Blood Pressure
Временное ограничение: Baseline and 12 weeks
|
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Diastolic Blood Pressure
Временное ограничение: Baseline and 12 weeks
|
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Fasting Glucose
Временное ограничение: Baseline and 12 weeks
|
Glucose was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Fasting Insulin
Временное ограничение: Baseline and 12 weeks
|
Insulin was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean 2-hour Glucose
Временное ограничение: Baseline and 12 weeks
|
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
|
Change From Baseline in Mean 2-hour Insulin
Временное ограничение: Baseline and 12 weeks
|
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
|
Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
Временное ограничение: 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).
|
Baseline and 12 weeks
|
Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Временное ограничение: 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.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Total Cholesterol
Временное ограничение: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean HDL Cholesterol
Временное ограничение: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean LDL Cholesterol
Временное ограничение: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Triglycerides
Временное ограничение: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Total Testosterone
Временное ограничение: Baseline and 12 weeks
|
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Free Testosterone
Временное ограничение: Baseline and 12 weeks
|
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
|
Baseline and 12 weeks
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change From Baseline in Mean 25-hydroxyvitamin D
Временное ограничение: Baseline and 12 weeks
|
Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Vitamin D Binding Protein
Временное ограничение: Baseline and 12 weeks
|
Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)
Временное ограничение: Baseline and 12 weeks
|
Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
|
Baseline and 12 weeks
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Nazia Raja-Khan, M.D., Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 29714
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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