NCT00907153

Brief Summary

The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

December 19, 2017

Completed
Last Updated

December 19, 2017

Status Verified

November 1, 2017

Enrollment Period

4.8 years

First QC Date

May 21, 2009

Results QC Date

March 10, 2017

Last Update Submit

November 20, 2017

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromeVitamin DInsulin resistanceInflammation

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)

    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

Secondary Outcomes (15)

  • Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)

    Baseline and 12 weeks

  • Change From Baseline in Mean Systolic Blood Pressure

    Baseline and 12 weeks

  • Change From Baseline in Mean Diastolic Blood Pressure

    Baseline and 12 weeks

  • Change From Baseline in Mean Fasting Glucose

    Baseline and 12 weeks

  • Change From Baseline in Mean Fasting Insulin

    Baseline and 12 weeks

  • +10 more secondary outcomes

Other Outcomes (3)

  • Change From Baseline in Mean 25-hydroxyvitamin D

    Baseline and 12 weeks

  • Change From Baseline in Mean Vitamin D Binding Protein

    Baseline and 12 weeks

  • Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)

    Baseline and 12 weeks

Study Arms (2)

Vitamin D

EXPERIMENTAL
Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

Vitamin D 300 mcg by mouth once daily for 12 weeks

Vitamin D
PlaceboDRUG

Placebo by mouth once daily for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Raja-Khan N, Shah J, Stetter CM, Lott ME, Kunselman AR, Dodson WC, Legro RS. High-dose vitamin D supplementation and measures of insulin sensitivity in polycystic ovary syndrome: a randomized, controlled pilot trial. Fertil Steril. 2014 Jun;101(6):1740-6. doi: 10.1016/j.fertnstert.2014.02.021. Epub 2014 Mar 14.

    PMID: 24636395RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceInflammation

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Nazia Raja-Khan
Organization
Penn State Hershey Medical Center
nrajakhan@psu.edu
717-531-8395

Study Officials

  • Nazia Raja-Khan, M.D.

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 22, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

December 19, 2017

Results First Posted

December 19, 2017

Record last verified: 2017-11

Locations

US(1)