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Mushrooms for Vitamin D Deficiency

N/A
Waitlist Available
Led By Wayne Campbell
Research Sponsored by Purdue University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight stable for 3 months prior (±3 kg)
Willing to refrain from taking vitamin D supplements or any supplements containing vitamin D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will explore if eating mushrooms with added vitamin D can improve vitamin D levels and immune function.

Who is the study for?
Adults with a BMI of 25-34.9, stable weight and physical activity, non-smokers, not severely depressed or diabetic, who don't take vitamin D supplements or have high cholesterol levels. Participants must eat mushrooms, avoid tanning procedures and sunny travel during the study.Check my eligibility
What is being tested?
The trial is testing if eating vitamin D-enriched mushrooms affects participants' vitamin D levels and improves immune function and inflammation compared to a control powder.See study design
What are the potential side effects?
Potential side effects are not specified for consuming vitamin D-enriched mushrooms but may include typical dietary reactions such as gastrointestinal discomfort or allergic responses in sensitive individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight has been stable, within 3 kg, for the last 3 months.
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I am willing to stop taking vitamin D supplements.
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I have never had weight loss surgery.
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I do not have diabetes.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in serum 25-hydroxy-vitamin D2 concentration
Secondary outcome measures
Body weight
Change in bone remodeling
Change in cognitive function from baseline to mid to post-intervention
+8 more

Side effects data

From 2015 Phase 3 trial • 486 Patients • NCT02014467
7%
Arthralgia
5%
Blood cholesterol increased
1%
Any event
1%
Femoral neck fracture
1%
Bone density decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab 60mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MushroomsExperimental Treatment1 Intervention
Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks.
Group II: No MushroomsPlacebo Group1 Intervention
This is a behavioral control where no change in Vitamin D status is expected to occur. Participants will consume their usual, unrestricted, self-selected diet plus 1 tsp of dried study powder twice daily for 12 weeks.

Find a Location

Who is running the clinical trial?

Purdue UniversityLead Sponsor
222 Previous Clinical Trials
72,602 Total Patients Enrolled
Wayne CampbellPrincipal InvestigatorPurdue University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accept individuals aged above 20 years?

"The cut-off for this research is between 30 and 69 years of age, with no exceptions."

Answered by AI

Am I eligible to enroll in this research study?

"This medical trial requires that potential participants must be between 30 and 69 years old, with documented vitamin d insufficiency. A total of 50 patients can take part in the study."

Answered by AI

Is it possible to enlist in this clinical trial at the present time?

"According to clinicaltrials.gov, this medical research is actively seeking patients; the trial was first posted on December 5th 2022 and most recently refreshed on February 14th 2023."

Answered by AI

How many participants are being recruited for this research project?

"Affirmative. The information available on clinicaltrials.gov states that this experiment is currently recruiting patients; it was first made public on December 5th 2022 and was last modified February 14th 2023. As of now, the trial seeks to enlist 50 participants from 1 medical centre."

Answered by AI

What objectives is this research striving to fulfill?

"The primary endpoint of this 12 week study is to observe changes in inflammatory markers. Additional results will be measured such as shifts seen in Osteocalcin, Parathyroid hormone (PTH), and Beck's Depression Inventory questionnaire scores from the beginning to mid-treatment and post-intervention points."

Answered by AI
~0 spots leftby Apr 2024