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Supplementation in Adolescent Girls With Endometriosis

NCT ID: NCT02387931

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-07-31

Brief Summary

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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

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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

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Endometriosis

Keywords

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Adolescent Endometriosis Diet Nutrition Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D

Vitamin D3 2000 IU daily taken for 6 months

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Nature Made Vitamin D 2000IU, 1 softgel taken daily

Fish Oil

Fish Oil 1000 mg daily for 6 months

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DIETARY_SUPPLEMENT

Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily

Placebo

Placebo taken daily for 6 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsule, 2 taken daily

Interventions

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Vitamin D3

Nature Made Vitamin D 2000IU, 1 softgel taken daily

Intervention Type DIETARY_SUPPLEMENT

Fish Oil

Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule, 2 taken daily

Intervention Type OTHER

Other Intervention Names

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Nature Made Vitamin D 2000IU Liquid softgels Nature Made ultra omega-3 mini fish oil 500mg, 2 daily Placebo capsule

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stacey Missmer

Stacey Missmer, ScD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stacey A Missmer, ScD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Brigham and Women's Hospital and Harvard Medical School

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32453393 (View on PubMed)

Other Identifiers

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P00007860

Identifier Type: -

Identifier Source: org_study_id