Supplementation in Adolescent Girls With Endometriosis

Endometriosis Clinical Trial

— SAGE  

Official title:

SAGE: Supplementation in Adolescent Girls With Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387931
• Other study ID #: P00007860
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2013
• Last updated: November 30, 2016
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Dietary Supplement:
• Vitamin D3
Nature Made Vitamin D 2000IU, 1 softgel taken daily
• Fish Oil
Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily

Other:
• Placebo
Placebo capsule, 2 taken daily

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometriosis pain	Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.	6 months	No
Secondary	Quality of life	Measured by change in SF-36 and EPHect questionnaires from baseline to 6 months.	6 months	No
Secondary	Pain medication usage	Measured via questionnaire of medication usage from baseline to 6 months.	6 months	No