EndometriosisPhase 4SAGENCT02387931
Supplementation in Adolescent Girls With Endometriosis
A Phase 4 study testing Vitamin D3 and Fish Oil in people with Endometriosis, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Vitamin D3 and Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: SAGE: Supplementation in Adolescent Girls With Endometriosis
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Vitamin D3, Fish Oil, Placebo
- Keywords
- Adolescent, Endometriosis, Diet, Nutrition, Pain
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Nature Made Vitamin D 2000IU Liquid softgels
Nature Made Vitamin D 2000IU, 1 softgel taken daily
Fish OilDietary supplement
Also called Nature Made ultra omega-3 mini fish oil 500mg, 2 daily
Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily
PlaceboOther
Also called Placebo capsule
Placebo capsule, 2 taken daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Vitamin D3 2000 IU daily taken for 6 months Receives: Dietary Supplement: Vitamin D3 |
| Fish Oil | Experimental | Fish Oil 1000 mg daily for 6 months Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | Placebo taken daily for 6 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometriosis pain
Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.
Measured: 6 months
Secondary outcomes (2)
Quality of life
Measured by change in SF-36 and EPHect questionnaires from baseline to 6 months.
Measured: 6 months
Pain medication usage
Measured via questionnaire of medication usage from baseline to 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey Missmer, Boston Children's Hospital
- Investigators
- Stacey A Missmer, ScD, Principal investigator, Department of Reproductive Medicine, Brigham and Women's Hospital and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387931
- Sponsor's protocol ID
- P00007860
- Acronym
- SAGE
- Status last verified
- Nov 2016
- First submitted
- 29 May 2013
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32453393
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAGE: Supplementation in Adolescent Girls With Endometriosis
- ClinicalTrials.gov ID
- NCT02387931
- Acronym / sponsor ID
- SAGE / P00007860
- Conditions
- Endometriosis
- Keywords
- Adolescent, Endometriosis, Diet, Nutrition, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin D3Vitamin D3 2000 IU daily taken for 6 months |
| Fish Oil | Experimental | Dietary Supplement: Fish OilFish Oil 1000 mg daily for 6 months |
| Placebo | Placebo comparator | Other: PlaceboPlacebo taken daily for 6 months. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Nature Made Vitamin D 2000IU Liquid softgelsNature Made Vitamin D 2000IU, 1 softgel taken daily | Dietary supplement | Vitamin D |
| Fish OilAlso: Nature Made ultra omega-3 mini fish oil 500mg, 2 dailyNature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily | Dietary supplement | Fish Oil |
| PlaceboAlso: Placebo capsulePlacebo capsule, 2 taken daily | Other | Placebo |
Primary outcome
Endometriosis pain
Time frame: 6 months
Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.
2 secondary outcomes
Quality of life
Time frame: 6 months
Pain medication usage
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Derived from this study: PubMed 32453393Nodler 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.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey A Missmer, ScD principal investigator
Department of Reproductive Medicine, Brigham and Women's Hospital and Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 and Fish Oil in people with Endometriosis, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.