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
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Dietary Supplement: Vitamin D3 Dietary Supplement: Fish Oil Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||SAGE: Supplementation in Adolescent Girls With Endometriosis|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Vitamin D
Vitamin D3 2000 IU daily taken for 6 months
Dietary Supplement: Vitamin D3
Nature Made Vitamin D 2000IU, 1 softgel taken daily
Other Name: Nature Made Vitamin D 2000IU Liquid softgels
Experimental: Fish Oil
Fish Oil 1000 mg daily for 6 months
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
Placebo Comparator: Placebo
Placebo taken daily for 6 months.
Placebo capsule, 2 taken daily
Other Name: Placebo capsule
- Endometriosis pain [ Time Frame: 6 months ]Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387931
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Stacey A Missmer, ScD||Department of Reproductive Medicine, Brigham and Women's Hospital and Harvard Medical School|