Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01488734
Eligibility Criteria:
Inclusion Criteria:
* Adult non-smoking subjects from ages 30 to 90, any race or gender
* Presence of at least two of the following characteristics:
* Waist circumference:
Men: \> 102 cm Women: \> 88 cm
* Blood pressure: \> 130/85 mm Hg (or use of anti-BP medication)
* HDL-cholesterol:
Men: \< 40 mg/dL Women: \< 50 mg/dL
* Triglycerides: \> 150 mg/dL (or use of medications for high triglycerides such as fibrates or nicotinic acid)
* Fasting blood sugar \> 100 mg/dl (or use of metformin), but a HbA1c \< 6.5%
Exclusion Criteria:
* Blood levels of 25(OH)D \> 50 nmol/L
* Regular intake of vitamin D fortified milk exceeding approximately 3 glasses/day
* Lack of the ability to comprehend instructions and/or sign the consent form
* Inability to comply with the potential requirement to eat a daily portion of provided mushroom together with meals
* Inability to comply with the rule of avoiding any beach days during the duration of the study
* Any projected trip to sunny places such as Puerto Rico and the Caribbean during the period of study
* Any attendance to tanning studios during the period of study
* Women who regularly use a veil over their heads
* Any history of kidney stone formation
* Non-traumatic bone fracture over the past 3 years
* Any form of vitamin D supplement intake, including combined calcium and vitamin D products
* Active smoking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
90 Years
Study:
NCT01488734
Study Brief:
Protocol Section:
NCT01488734