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Supplementation in Adolescent Girls With Endometriosis (SAGE)

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ClinicalTrials.gov Identifier: NCT02387931
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Stacey Missmer, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Endometriosis Dietary Supplement: Vitamin D3 Dietary Supplement: Fish Oil Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: SAGE: Supplementation in Adolescent Girls With Endometriosis
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitamin D
Vitamin D3 2000 IU daily taken for 6 months
Dietary Supplement: Vitamin D3
Nature Made Vitamin D 2000IU, 1 softgel taken daily
Other Name: Nature Made Vitamin D 2000IU Liquid softgels

Experimental: Fish Oil
Fish Oil 1000 mg daily for 6 months
Dietary Supplement: Fish Oil
Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily
Other Name: Nature Made ultra omega-3 mini fish oil 500mg, 2 daily

Placebo Comparator: Placebo
Placebo taken daily for 6 months.
Other: Placebo
Placebo capsule, 2 taken daily
Other Name: Placebo capsule




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387931


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Stacey A Missmer, ScD Department of Reproductive Medicine, Brigham and Women's Hospital and Harvard Medical School

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Responsible Party: Stacey Missmer, Stacey Missmer, ScD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02387931     History of Changes
Other Study ID Numbers: P00007860
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Keywords provided by Stacey Missmer, Boston Children’s Hospital:
Adolescent
Endometriosis
Diet
Nutrition
Pain
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents