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Trial record 47 of 566 for:    "Polycystic Ovary Syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00907153
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Nazia Raja-Khan, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Polycystic Ovary Syndrome
Interventions Dietary Supplement: Vitamin D
Drug: Placebo
Enrollment 36
Recruitment Details 36 patients were screened for eligibility between July 2009 and November 2010 at Medicine and Obstetrics and Gynecology clinics at an academic medical center in Hershey, PA.
Pre-assignment Details 28 of 36 participants were randomized. Of those not randomized, 3 did not meet inclusion criteria, 3 declined to participate, and 2 were not randomized for other reasons.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks Placebo: Placebo by mouth once daily for 12 weeks
Period Title: Overall Study
Started 13 15
Completed 11 11
Not Completed 2 4
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             1             3
Arm/Group Title Vitamin D Placebo Total
Hide Arm/Group Description Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks Placebo: Placebo by mouth once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 13 15 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 28 participants
28.2  (5.2) 28.7  (5.6) 28.5  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Female
13
 100.0%
15
 100.0%
28
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.7%
0
   0.0%
1
   3.6%
White
10
  76.9%
14
  93.3%
24
  85.7%
More than one race
1
   7.7%
0
   0.0%
1
   3.6%
Unknown or Not Reported
1
   7.7%
1
   6.7%
2
   7.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 15 participants 28 participants
13 15 28
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 13 participants 15 participants 28 participants
37.20  (4.53) 35.09  (9.81) 36.1  (7.8)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 13 participants 15 participants 28 participants
117.46  (10.00) 113.91  (10.21) 115.56  (10.11)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm hg
Number Analyzed 13 participants 15 participants 28 participants
79.08  (8.28) 74.88  (7.72) 76.83  (7.98)
25-hydroxyvitamin D  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 13 participants 15 participants 28 participants
19.95  (9.47) 22.20  (6.86) 21.15  (8.10)
Vitamin D binding protein  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 15 participants 28 participants
30.46  (8.53) 31.95  (7.54) 31.34  (8.04)
Intact parathyroid hormone (i-PTH)  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 13 participants 15 participants 28 participants
40.81  (27.34) 33.17  (17.73) 36.72  (22.19)
Fasting glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 15 participants 28 participants
84.92  (9.46) 83.73  (9.33) 84.29  (9.23)
Fasting insulin  
Mean (Standard Deviation)
Unit of measure:  uU/mL
Number Analyzed 13 participants 15 participants 28 participants
26.31  (9.60) 27.13  (15.79) 26.75  (13.05)
2-hour glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 15 participants 28 participants
122.08  (36.29) 110.07  (23.68) 115.64  (30.22)
2-hour insulin  
Mean (Standard Deviation)
Unit of measure:  uU/mL
Number Analyzed 13 participants 15 participants 28 participants
214.69  (146.41) 107.07  (55.20) 157.04  (118.72)
Insulin sensitivity index 0,120   [1] 
Mean (Standard Deviation)
Unit of measure:  mg·l^2/mmol·mU·min
Number Analyzed 13 participants 15 participants 28 participants
55.55  (23.26) 63.56  (16.37) 59.84  (19.57)
[1]
Measure Description: 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).
Quantitative Insulin Sensitivity Check Index (QUICKI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 15 participants 28 participants
0.302  (0.014) 0.307  (0.029) 0.305  (0.022)
[1]
Measure Description: The primary outcome was quantitative insulin sensitivity check index (QUICKI), 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))]).
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 15 participants 28 participants
5.47  (1.82) 5.80  (3.90) 5.65  (2.93)
[1]
Measure Description: HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5.
Total cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 15 participants 28 participants
172.00  (42.70) 184.27  (32.52) 178.57  (37.38)
HDL cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 15 participants 28 participants
45.54  (17.60) 37.00  (10.83) 40.96  (14.74)
LDL cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 15 participants 28 participants
98.62  (36.96) 117.33  (28.56) 108.64  (33.47)
Triglyecrides  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 15 participants 28 participants
139.08  (71.61) 149.47  (85.46) 144.64  (78.07)
High sensitive C-reactive protein (hsCRP)  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 13 participants 15 participants 28 participants
7.95  (5.24) 4.42  (4.34) 6.1  (5.0)
Total testosterone  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 13 participants 15 participants 28 participants
54.23  (28.16) 41.27  (17.29) 48.48  (23.03)
Free testosterone  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 13 participants 15 participants 28 participants
19.08  (15.79) 14.00  (10.88) 16.89  (13.33)
1.Primary Outcome
Title Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
Hide Description 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))]).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.008
(-0.020 to 0.004)
0.009
(-0.003 to 0.021)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.017
Confidence Interval (2-Sided) 95%
-0.034 to -0.000
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
Hide Description High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/L
0.90
(-2.46 to 4.27)
2.04
(-1.37 to 5.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.14
Confidence Interval (2-Sided) 95%
-5.89 to 3.62
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Systolic Blood Pressure
Hide Description Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
0.64
(-7.13 to 8.42)
4.29
(-3.15 to 11.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.65
Confidence Interval (2-Sided) 95%
-14.32 to 7.02
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Diastolic Blood Pressure
Hide Description Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-0.91
(-4.96 to 3.14)
5.60
(1.69 to 9.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.51
Confidence Interval (2-Sided) 95%
-12.07 to -0.96
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Mean Fasting Glucose
Hide Description Glucose was assessed after 12 hours of fasting.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-0.70
(-7.96 to 6.56)
-6.98
(-14.31 to 0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.28
Confidence Interval (2-Sided) 95%
-3.97 to 16.54
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Mean Fasting Insulin
Hide Description Insulin was assessed after 12 hours of fasting.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: uU/mL
13.04
(-3.96 to 30.05)
-0.80
(-18.03 to 16.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.84
Confidence Interval (2-Sided) 95%
-210.29 to 37.98
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Mean 2-hour Glucose
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-11.66
(-33.22 to 9.89)
1.14
(-20.10 to 22.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -12.80
Confidence Interval (2-Sided) 95%
-42.94 to 17.34
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Mean 2-hour Insulin
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: uU/mL
-62.02
(-124.5 to 0.49)
13.06
(-47.94 to 74.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -75.08
Confidence Interval (2-Sided) 95%
-161.9 to 11.78
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg·l^2/mmol·mU·min
6.67
(-16.87 to 30.21)
5.94
(-17.77 to 29.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
-32.59 to 34.06
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.57
(-0.90 to 6.03)
-0.51
(-4.01 to 2.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.08
Confidence Interval (2-Sided) 95%
-1.84 to 7.99
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Mean Total Cholesterol
Hide Description Lipid profile was assessed after 12 hours of fasting.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-1.69
(-19.04 to 15.66)
-1.80
(-19.55 to 15.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-24.43 to 24.64
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Mean HDL Cholesterol
Hide Description Lipid profile was assessed after 12 hours of fasting.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-0.70
(-6.52 to 5.12)
1.23
(-4.68 to 7.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.93
Confidence Interval (2-Sided) 95%
-10.12 to 6.26
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Mean LDL Cholesterol
Hide Description Lipid profile was assessed after 12 hours of fasting.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-0.12
(-14.70 to 14.46)
-0.40
(-15.24 to 14.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-20.29 to 20.85
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Mean Triglycerides
Hide Description Lipid profile was assessed after 12 hours of fasting.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-2.21
(-34.11 to 29.69)
-12.44
(-44.68 to 19.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.24
Confidence Interval (2-Sided) 95%
-34.61 to 55.08
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Mean Total Testosterone
Hide Description Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: ng/dL
3.01
(-8.05 to 14.06)
10.16
(-1.16 to 21.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
-22.81 to 8.51
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Mean Free Testosterone
Hide Description Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: ng/dL
2.67
(-1.29 to 6.63)
5.82
(1.82 to 9.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.15
Confidence Interval (2-Sided) 95%
-8.70 to 2.41
Estimation Comments [Not Specified]
17.Other Pre-specified Outcome
Title Change From Baseline in Mean 25-hydroxyvitamin D
Hide Description Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
45.63
(33.50 to 57.76)
1.32
(-10.93 to 13.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 44.31
Confidence Interval (2-Sided) 95%
27.13 to 61.48
Estimation Comments [Not Specified]
18.Other Pre-specified Outcome
Title Change From Baseline in Mean Vitamin D Binding Protein
Hide Description Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
1.01
(-1.60 to 3.62)
-0.55
(-3.14 to 2.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
-2.08 to 5.20
Estimation Comments [Not Specified]
19.Other Pre-specified Outcome
Title Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)
Hide Description Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo: Placebo by mouth once daily for 12 weeks
Overall Number of Participants Analyzed 13 15
Mean (95% Confidence Interval)
Unit of Measure: pg/mL
-24.28
(-39.80 to -8.76)
-16.45
(-31.40 to -1.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Regression, Linear
Comments Model-based differences adjusted for oral contraceptive use and season.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.84
Confidence Interval (2-Sided) 95%
-29.34 to 13.67
Estimation Comments [Not Specified]
Time Frame Twelve weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks Placebo: Placebo by mouth once daily for 12 weeks
All-Cause Mortality
Vitamin D Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin D Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin D Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Nazia Raja-Khan
Organization: Penn State Hershey Medical Center
Phone: 717-531-8395
Responsible Party: Nazia Raja-Khan, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00907153     History of Changes
Other Study ID Numbers: 29714
First Submitted: May 21, 2009
First Posted: May 22, 2009
Results First Submitted: March 10, 2017
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017