Supplementation in Adolescent Girls With Endometriosis

Study Overview
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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.

Official Title
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SAGE: Supplementation in Adolescent Girls With Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Fish Oil
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Vitamin D3 2000 IU daily taken for 6 months | Dietary Supplement: Vitamin D3<br>* Nature Made Vitamin D 2000IU, 1 softgel taken daily<br>* Other names: Nature Made Vitamin D 2000IU Liquid softgels;|
| Experimental: Fish Oil<br>Fish Oil 1000 mg daily for 6 months | Dietary Supplement: Fish Oil<br>* Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily<br>* Other names: Nature Made ultra omega-3 mini fish oil 500mg, 2 daily;|
| Placebo Comparator: Placebo<br>Placebo taken daily for 6 months. | Other: Placebo<br>* Placebo capsule, 2 taken daily<br>* Other names: Placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometriosis pain | Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Measured by change in SF-36 and EPHect questionnaires from baseline to 6 months. | 6 months | 
| Pain medication usage | Measured via questionnaire of medication usage from baseline to 6 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Endometriosis, Diet, Nutrition, Pain