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Completed

NCT Number: NCT02387931

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.

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Key information

Age range

12 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

Nature Made Vitamin D 2000IU, 1 softgel taken daily

Other names: Nature Made Vitamin D 2000IU Liquid softgels

Fish Oil

Dietary Supplement

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

Other names: Nature Made ultra omega-3 mini fish oil 500mg, 2 daily

Placebo

Other

Placebo capsule, 2 taken daily

Other names: Placebo capsule

Primary outcomes

  1. Endometriosis pain

    Time frame: 6 months

    Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.

Secondary outcomes

  1. Quality of life

    Time frame: 6 months

    Measured by change in SF-36 and EPHect questionnaires from baseline to 6 months.

  2. Pain medication usage

    Time frame: 6 months

    Measured via questionnaire of medication usage from baseline to 6 months.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

SAGE: Supplementation in Adolescent Girls With Endometriosis

Acronym: SAGE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2015
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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