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Trial record 40 of 390 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Vitamin D 50,000 IU Weekly 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)
Placebo 50,000 IU Weekly If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
Vitamin D 2,000 IU Daily 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)
Placebo 2,000 IU Daily If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)

Participant Flow:   Overall Study
    Vitamin D 50,000 IU Weekly   Placebo 50,000 IU Weekly   Vitamin D 2,000 IU Daily   Placebo 2,000 IU Daily
STARTED   1   3   2   1 
COMPLETED   1   3   2   1 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Vitamin D 50,000 IU Weekly 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)
Placebo 50,000 IU Weekly If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
Vitamin D 2,000 IU Daily 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)
Placebo 2,000 IU Daily 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 Total of all reporting groups

Baseline Measures
   Vitamin D 50,000 IU Weekly   Placebo 50,000 IU Weekly   Vitamin D 2,000 IU Daily   Placebo 2,000 IU Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   3   2   1   7 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   1   3   2   1   7 
>=65 years   0   0   0   0   0 
Gender 
[Units: Participants]
         
Female   1   3   2   1   7 
Male   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
         
United States   1   3   2   1   7 


  Outcome Measures

1.  Primary:   The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention   [ Time Frame: Up to 24 months ]

2.  Primary:   Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention   [ Time Frame: Up to 24 months ]

3.  Secondary:   Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers   [ Time Frame: Up to 24 months ]

4.  Secondary:   Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.   [ Time Frame: Up to 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: dcarson@nm.org



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