Boston Children's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT02387931
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.
Looking for future studies?
Notify Me12 year–25 year
Female
Interventional
Phase 4
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nature Made Vitamin D 2000IU, 1 softgel taken daily
Other names: Nature Made Vitamin D 2000IU Liquid softgels
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 capsule, 2 taken daily
Other names: Placebo capsule
Time frame: 6 months
Measured by change in the score of the visual analog scale (VAS) from baseline to 6 months.
Time frame: 6 months
Measured by change in SF-36 and EPHect questionnaires from baseline to 6 months.
Time frame: 6 months
Measured via questionnaire of medication usage from baseline to 6 months.
Boston Children's Hospital
Other
SAGE: Supplementation in Adolescent Girls With Endometriosis
Acronym: SAGE
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.
Published trials that share one or more normalized conditions with this study.
NCT06517654
Dyssomnias, Endometriosis
Üsküdar, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06073379
Endometriosis, Female Urogenital Diseases
Dijon, France
View Trial DetailsNCT07328061
Anxiety Disorders, Endometriosis
Ramat Gan, Central District, Israel
View Trial DetailsNCT07245537
Endometriosis, Female Urogenital Diseases
Modena, Emilia-Romagna, Italy
View Trial Details