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Trial record 1 of 1 for:    "Endometriosis" | "Sage"
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Supplementation in Adolescent Girls With Endometriosis (SAGE)

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ClinicalTrials.gov Identifier: NCT02387931
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Stacey Missmer, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE March 13, 2015
Last Update Posted Date December 1, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
Endometriosis pain [ Time Frame: 6 months ]
Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02387931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
  • Quality of life [ Time Frame: 6 months ]
    Measured by change in SF-36 and EPHect questionnaires from baseline to 6 months.
  • Pain medication usage [ Time Frame: 6 months ]
    Measured via questionnaire of medication usage from baseline to 6 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supplementation in Adolescent Girls With Endometriosis
Official Title  ICMJE SAGE: Supplementation in Adolescent Girls With Endometriosis
Brief Summary The purpose of this study is to determine whether dietary supplementation with Vitamin D or Fish Oil can help to reduce physical and emotional symptoms in adolescent girls with endometriosis.
Detailed Description This is a randomized controlled trial designed to evaluate the effect of dietary supplementation on endometriosis symptom remediation. Adolescent and young adults females aged 12 to 25 years with a surgically-confirmed diagnosis of endometriosis will be eligible for study participation. Subjects will be excluded if they have concurrent chronic illnesses that affect gastrointestinal absorption of nutrients (e.g., celiac disease, IBD, cystic fibrosis), a history of renal stones, are pregnant, or non-English speaking. Once consented, subjects will be randomized to one of 3 treatment assignments: 1) vitamin D3 2000 IU daily (n=30), 2) fish oil 1000 mg daily (n=30), 3) placebo (n=30) and will take these daily for 6 months. Baseline nutrient intake from food and supplements will be assessed using the Food Frequency Questionnaire (FFQ). The 142 item survey assesses usual dietary intake during the past year. Validated rating scales including the visual analog scale (VAS), SF-36, and the World Endometriosis EPHect questionnaires will be used to measure pain and overall quality of life. The SF-36 measures 8 health concepts relevant across disease groups, including limitations to physical or social activities because of health problems, vitality, and general health perception. Patients will complete a full review of medication usage, past medical history, family history, and other lifestyle factors. Anthropometrics will be measured, and vital signs obtained. Measures will be repeated at 3-month intervals for a total of 6 months. Blood will be drawn at baseline, and at 6 months to measure levels of fatty acids, vitamin D, parathyroid hormone (PTH), and calcium.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Dietary Supplement: Vitamin D3
    Nature Made Vitamin D 2000IU, 1 softgel taken daily
    Other Name: Nature Made Vitamin D 2000IU Liquid softgels
  • Dietary Supplement: Fish Oil
    Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily
    Other Name: Nature Made ultra omega-3 mini fish oil 500mg, 2 daily
  • Other: Placebo
    Placebo capsule, 2 taken daily
    Other Name: Placebo capsule
Study Arms  ICMJE
  • Experimental: Vitamin D
    Vitamin D3 2000 IU daily taken for 6 months
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: Fish Oil
    Fish Oil 1000 mg daily for 6 months
    Intervention: Dietary Supplement: Fish Oil
  • Placebo Comparator: Placebo
    Placebo taken daily for 6 months.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
69
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2015)
100
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • Age 12 years -25 years
  • Previously surgically diagnosed at Boston Children's Hospital with endometriosis
  • At least 6 weeks following laparoscopy
  • Minimum pain score within the 4 weeks preceding study baseline
  • Must be able to swallow an empty 00 gelatin capsule at baseline
  • Must be willing to stop all vitamins and nutritional supplements during trial

Exclusion Criteria:

  • Concurrent chronic illnesses that affect gastrointestinal absorption of nutrients (e.g., celiac disease, IBD, cystic fibrosis)
  • Vitamin D level of greater than or equal to 100 ng/ml at study baseline
  • History of renal stones
  • No access to text messages or email
  • Pregnancy
  • Non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02387931
Other Study ID Numbers  ICMJE P00007860
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stacey Missmer, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stacey A Missmer, ScD Department of Reproductive Medicine, Brigham and Women's Hospital and Harvard Medical School
PRS Account Boston Children’s Hospital
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP