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Omega-3 + Vitamin D for Type 1 Diabetes (POSEIDON Trial)
POSEIDON Trial Summary
This trial will test if a combination of Omega-3 Fatty Acids and Vitamin D are safe and effective, considering when and how long they are taken.
POSEIDON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPOSEIDON Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.POSEIDON Trial Design
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Who is running the clinical trial?
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- I haven't received any live vaccines in the last 6 weeks.I do not have any current severe infections.I haven't taken immunosuppressives or similar drugs in the last 3 months.You have a body mass index (BMI) higher than 30, which means you are very overweight.People with eating disorders are not eligible.You have a history of using illegal drugs or abusing alcohol.I have had Type 1 Diabetes for less than 10 years and my C-peptide levels are adequate.I can have blood drawn without difficulty.I am not allergic to Omega-3 or Vitamin-D, including fish or shellfish.I am taking medication that can change my weight, like Orlistat.I am using or plan to use diabetes medications besides insulin.I have used diabetes medication other than insulin in the last week.I have had cancer before, but not prostate cancer or any that spread widely.I do not have any blood, bleeding, or coagulation disorders.I (or my parents, if I'm under 18) understand and agree to participate in the study.I was diagnosed with type 1 diabetes less than 6 months ago and my C-peptide test shows some insulin production.I am of childbearing age and have a negative pregnancy test.Your liver enzymes (AST, ALT, Alkaline Phosphatase) or bilirubin levels are too high.I have a history of cancer.I have a history of severe stomach or digestive problems.I have Type 1 Diabetes and tested positive for specific diabetes-related autoantibodies.I do not take medication that affects bleeding, like blood thinners or NSAIDs.I have not had heart failure, fluid overload, heart attack, severe liver disease, or major organ impairment in the last 6 weeks.I am between 6 and 65 years old.I have received an organ transplant.I am between 6 and 65 years old.I do not have any chronic infections like hepatitis, TB, or HIV.
- Group 1: Omega-3 and Vitamin D Combination
- Group 2: Vitamin D Only
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Am I eligible to join this research endeavor?
"This medical study is seeking out 56 individuals between the ages of 6 and 65 that suffer from hypoglycemia. To be eligible, applicants must meet certain conditions: they or their guardians (if under 18) should possess understanding in order to provide informed consent; males and females are equally welcome; those with newly-diagnosed type 1 diabetes should have had it for fewer than 180 days prior to randomization and present a MMTT stimulated C-peptide peak level above 0.2 ng/ml before enrollment; established T1D patients will need more than 180 days but less than 10 years from diagnosis along with the same aforementioned"
Is this clinical study currently recruiting participants?
"Indeed, clinicaltrials.gov confirms that this medical investigation is actively enrolling participants. Initially posted on July 23rd 2018, the trial was recently updated on August 9th 2022 and is searching for 56 volunteers from one location."
What medicinal benefits are generally associated with Omega-3 and Vitamin D Combination treatments?
"Omega-3 and Vitamin d Combination can be employed as a treatment for calcium deficiency, fractures, and spine fractures."
Have any other investigations explored the synergistic effects of Omega-3 and Vitamin D?
"At present, there are 57 research trials examining the potential of Omega-3 and Vitamin d Combination, with 21 already in their concluding phase. In Dallas alone, several clinical studies have been conducted on this combination; however, 191 sites across the world are running similar experiments."
Is participation in this trial restricted to individuals under the age of 55?
"This research study is seeking participants aged between 6 and 65. For those younger than 6, there are 239 trials available; for seniors older than 65, 977 studies exist."
How many individuals have enrolled in this experimental research?
"Yes, the clinicaltrials.gov page confirms that this medical trial is presently recruiting participants; it was initially posted on July 23rd 2018 and has been recently updated August 9th 2022. The research requires 56 individuals to be enrolled at a single site."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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