Phase 2 N=28 Randomized Double-blind Treatment

Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00907153 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) — -0.008; 0.009 units on a scale — p=0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Vitamin D (Dietary_supplement); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Milton S. Hershey Medical Center
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)	-0.008; 0.009	0.05
SECONDARY Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)	0.90; 2.04	0.62
SECONDARY Change From Baseline in Mean Systolic Blood Pressure	0.64; 4.29	0.48
SECONDARY Change From Baseline in Mean Diastolic Blood Pressure	-0.91; 5.60	0.02 sig
SECONDARY Change From Baseline in Mean Fasting Glucose	-0.70; -6.98	0.22
SECONDARY Change From Baseline in Mean Fasting Insulin	13.04; -0.80	0.33
SECONDARY Change From Baseline in Mean 2-hour Glucose	-11.66; 1.14	0.39
SECONDARY Change From Baseline in Mean 2-hour Insulin	-62.02; 13.06	0.09
SECONDARY Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)	6.67; 5.94	0.96
SECONDARY Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	2.57; -0.51	0.21
SECONDARY Change From Baseline in Mean Total Cholesterol	-1.69; -1.80	0.99
SECONDARY Change From Baseline in Mean HDL Cholesterol	-0.70; 1.23	0.62
SECONDARY Change From Baseline in Mean LDL Cholesterol	-0.12; -0.40	0.98
SECONDARY Change From Baseline in Mean Triglycerides	-2.21; -12.44	0.64
SECONDARY Change From Baseline in Mean Total Testosterone	3.01; 10.16	0.88
SECONDARY Change From Baseline in Mean Free Testosterone	2.67; 5.82	0.25

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00907153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.