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- Essai clinique NCT00907153
Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033
- Penn State College of Medicine, Penn State Milton S Hershey Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
|
Placebo by mouth once daily for 12 weeks
|
Expérimental: Vitamine D
|
Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 12 weeks
|
Glucose was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Fasting Insulin
Délai: Baseline and 12 weeks
|
Insulin was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean 2-hour Glucose
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean HDL Cholesterol
Délai: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean LDL Cholesterol
Délai: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Triglycerides
Délai: Baseline and 12 weeks
|
Lipid profile was assessed after 12 hours of fasting.
|
Baseline and 12 weeks
|
Change From Baseline in Mean Total Testosterone
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change From Baseline in Mean 25-hydroxyvitamin D
Délai: 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
Délai: 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)
Délai: Baseline and 12 weeks
|
Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
|
Baseline and 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nazia Raja-Khan, M.D., Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Tumeurs
- Maladies du système endocrinien
- Maladie
- Kystes de l'ovaire
- Kystes
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Syndrome des ovaires polykystiques
- Syndrome
- Effets physiologiques des médicaments
- Micronutriments
- Vitamines
- Agents de conservation de la densité osseuse
- Vitamine D
Autres numéros d'identification d'étude
- 29714
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Essais cliniques sur Vitamin D
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Johnson & Johnson Consumer Inc. (J&JCI)Complété
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Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ComplétéAnémie de la maladie rénale chroniqueÉtats-Unis