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Trial record 40 of 399 for:    Lymphoma AND (women OR woman OR female)

Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT01744821
Recruitment Status : Terminated (Inability to recruit study subjects)
First Posted : December 7, 2012
Results First Posted : March 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Interventions Dietary Supplement: Arm A: Vitamin D3 Group
Dietary Supplement: Placebo
Enrollment 7
Recruitment Details Eligible participants were women at high risk for ovarian cancer and undergoing a prophylactic salpingo-oophorectomy. Subjects were recruited in the outpatient gynecologic oncology clinics of the study investigators. The study opened 6/1/12 with a goal of 80 subjects. It closed on 1/12/15 with a total of 7 subjects.
Pre-assignment Details Baseline evaluation included physical examination, personal and family history questionnaire, and blood test including serum 25(OH)D. Based on vitamin D level, subjects were randomized to 1 of 4 groups.
Arm/Group Title Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Hide Arm/Group Description If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks) If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks) If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week) If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
Period Title: Overall Study
Started 1 3 2 1
Completed 1 3 2 1
Not Completed 0 0 0 0
Arm/Group Title Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily Total
Hide Arm/Group Description If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks) If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks) If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week) If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks) Total of all reporting groups
Overall Number of Baseline Participants 1 3 2 1 7
Hide Baseline Analysis Population Description
With a total of 80 patients (40 per arm), assuming a Type I error rate of 5% and a power of 80, an effect size of 0.63 may be detected between patients exposed to Vitamin D supplementation and those not exposed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 2 participants 1 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
3
 100.0%
2
 100.0%
1
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 2 participants 1 participants 7 participants
Female
1
 100.0%
3
 100.0%
2
 100.0%
1
 100.0%
7
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 3 participants 2 participants 1 participants 7 participants
1 3 2 1 7
1.Primary Outcome
Title The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention
Hide Description Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical.
Time Frame Up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.
Arm/Group Title Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Hide Arm/Group Description:
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention
Hide Description Decrease in cellular proliferation measured by immunohistochemistry staining with KI67
Time Frame Up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.
Arm/Group Title Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Hide Arm/Group Description:
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers
Hide Description

The outcomes that will be measured for the secondary objectives of this study will include the following:

Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24

Time Frame Up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.
Arm/Group Title Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Hide Arm/Group Description:
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
Hide Description Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D
Time Frame Up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Hide Arm/Group Description:
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
Overall Number of Participants Analyzed 1 3 2 1
Measure Type: Number
Unit of Measure: participants
Fatige grade 1 1 0 0 0
Headache grade 1 0 1 1 0
Hypercalcemia 0 0 0 0
Loss of Appetite grade 1 0 1 0 0
Dry Mouth grade 1 1 1 0 0
Constipation grade 1 1 0 0 0
Weakness grade 1 1 0 0 0
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Hide Arm/Group Description If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks) If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks) If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week) If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
All-Cause Mortality
Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin D 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/3 (0.00%)      0/2 (0.00%)      0/1 (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 50,000 IU Weekly Placebo 50,000 IU Weekly Vitamin D 2,000 IU Daily Placebo 2,000 IU Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/3 (33.33%)      2/2 (100.00%)      0/1 (0.00%)    
Gastrointestinal disorders         
Constipation  1 [1]  1/1 (100.00%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Dry Mouth  1 [1]  1/1 (100.00%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
General disorders         
Fatigue  1 [1]  1/1 (100.00%)  1 0/3 (0.00%)  0 2/2 (100.00%)  2 0/1 (0.00%)  0
Metabolism and nutrition disorders         
Loss of Appetite  1 [1]  0/1 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Weakness  1 [2]  1/1 (100.00%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders         
Headache  1 [1]  0/1 (0.00%)  0 1/3 (33.33%)  1 1/2 (50.00%)  1 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Grade 1
[2]
Grade1
Low accrual led to this pilot study closing early. Accrual barriers included the 4-week minimum treatment time frame and narrow eligibility criteria. Small numbers prohibit meaningful analysis. Study provides important insights to recruitment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Assistant Professor
Organization: Northwestern University
Phone: 312-472-4684
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01744821     History of Changes
Other Study ID Numbers: STU00064898
First Submitted: November 30, 2012
First Posted: December 7, 2012
Results First Submitted: March 17, 2015
Results First Posted: March 23, 2015
Last Update Posted: July 23, 2015