Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01721915
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2012-10-31
Brief Title:
Vitamin D Treatment Pharmacogenetics and Glucose Metabolism
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Metabolic and Fertility Parameters in PCOS Women
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Polycystic ovary syndrome PCOS is as common as 5-10 of all women in Austria PCOS women frequently present with metabolic disturbances hyperandrogenism and infertility New therapy concepts are warranted In our recent pilot study vitamin D vitD supplementation significantly improved glucose metabolism and fertility However the efficacy of vitD administration shows individual variability indicating endogenous influences on pharmacological effects
A recent genome-wide association study reported three loci DHCR7 CYP2R1 and GC associated with vitD insufficiency Moreover vitD receptor VDR gene variants have already been known to be associated with insulin resistance
Aim To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD related genetic determinants adjusted for environmental factors
Primary outcome Change from baseline in AUCgluc after vitD treatment Secondary outcome To generate the hypothesis that changes in metabolic and endocrine parameters following vitD treatment are associated with vitD related gene variants
Methods 150 PCOS women with 25-hydroxyvitamin D cholecalciferol 25OHD levels 30 ngml will be treated with vitD 20000 IUwk or placebo in a 21 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants In addition 150 non-PCOS women with 25OHD 30 ngml will be treated with vitD 20000 IUwk or placebo in a 21 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants The response to vitD supplementation in both groups will be analysed according to genotype profiles
Significance VitD might be a new therapeutic option without major side effects for PCOS patients Exploring specific loci for pharmacogenetic vitD actions would open a new window for therapy modulation in PCOS and other metabolic diseases
A recent genome-wide association study reported three loci DHCR7 CYP2R1 and GC associated with vitD insufficiency Moreover vitD receptor VDR gene variants have already been known to be associated with insulin resistance
Aim To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD related genetic determinants adjusted for environmental factors
Primary outcome Change from baseline in AUCgluc after vitD treatment Secondary outcome To generate the hypothesis that changes in metabolic and endocrine parameters following vitD treatment are associated with vitD related gene variants
Methods 150 PCOS women with 25-hydroxyvitamin D cholecalciferol 25OHD levels 30 ngml will be treated with vitD 20000 IUwk or placebo in a 21 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants In addition 150 non-PCOS women with 25OHD 30 ngml will be treated with vitD 20000 IUwk or placebo in a 21 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants The response to vitD supplementation in both groups will be analysed according to genotype profiles
Significance VitD might be a new therapeutic option without major side effects for PCOS patients Exploring specific loci for pharmacogenetic vitD actions would open a new window for therapy modulation in PCOS and other metabolic diseases
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KLI 274 | OTHER_GRANT | Austrian Science Fund FWF | None |