Supplementation in Adolescent Girls With Endometriosis

Status Completed

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.

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT02387931
Study type	Interventional
Source	Boston Children’s Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	September 2014
Completion date	July 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01931670` - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Recruiting	`NCT05648669` - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Completed	`NCT04665414` - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed	`NCT03690765` - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting	`NCT05153512` - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting	`NCT04171297` - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting	`NCT04172272` - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	N/A
Completed	`NCT04565470` - Strategies of Self-management of Endometriosis Symptoms
Completed	`NCT03613298` - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.	N/A
Withdrawn	`NCT05568940` - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting	`NCT03464799` - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting	`NCT03002870` - Characteristics of Patient Population With Endometriosis	N/A
Withdrawn	`NCT03272360` - Endometriosis Biomarker Discovery Study	N/A
Completed	`NCT02973854` - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting	`NCT02481739` - Laparoscopic Surgical Management of Endometriosis on Fertility	N/A
Active, not recruiting	`NCT02754648` - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve	N/A
Completed	`NCT06106932` - GnRH-a on Angiogenesis of Endometriosis	N/A
Completed	`NCT01939535` - Preoperative Staging of Endometriosis With MRI	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Supplementation in Adolescent Girls With Endometriosis — SAGE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms