Supplementation in Adolescent Girls With Endometriosis
SAGE
SAGE: Supplementation in Adolescent Girls With Endometriosis
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedDecember 1, 2016
November 1, 2016
1.8 years
May 29, 2013
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endometriosis pain
Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.
6 months
Secondary Outcomes (2)
Quality of life
6 months
Pain medication usage
6 months
Study Arms (3)
Vitamin D
EXPERIMENTALVitamin D3 2000 IU daily taken for 6 months
Fish Oil
EXPERIMENTALFish Oil 1000 mg daily for 6 months
Placebo
PLACEBO COMPARATORPlacebo taken daily for 6 months.
Interventions
Nature Made Vitamin D 2000IU, 1 softgel taken daily
Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Nodler JL, DiVasta AD, Vitonis AF, Karevicius S, Malsch M, Sarda V, Fadayomi A, Harris HR, Missmer SA. Supplementation with vitamin D or omega-3 fatty acids in adolescent girls and young women with endometriosis (SAGE): a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2020 Jul 1;112(1):229-236. doi: 10.1093/ajcn/nqaa096.
PMID: 32453393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacey A Missmer, ScD
Department of Reproductive Medicine, Brigham and Women's Hospital and Harvard Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Stacey Missmer, ScD
Study Record Dates
First Submitted
May 29, 2013
First Posted
March 13, 2015
Study Start
September 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
December 1, 2016
Record last verified: 2016-11