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:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT01497132
Eligibility Criteria:
Inclusion Criteria:
* Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
* BMI ≤ 32 kg/m2.
* HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
* Fasting plasma glucose \< 9 mmol/l
* S-25-OH-vitamin D3 \< 75 nmol/l.
Exclusion Criteria:
* Treatment with any vitamin D preparation.
* Regular sun-bathing in solarium.
* Hypercalcemia at screening, defined as free s-calcium \> 1.35 mmol/l.
* Hyperphosphatemia at screening, defined as s-phosphate \> 1.5 mmol/l.
* Sarcoidosis or other granulomatous disease.
* Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
* Impaired hepatic function.
* Impaired renal function
* Cardiac disease defined as:
* Unstable angina pectoris
* Myocardial infarction within the last 6 months
* Congestive heart failure NYHA class III and IV
* Cerebral stroke within the last 6 months.
* Anti-diabetic medication of any kind.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT01497132
Study Brief:
Protocol Section:
NCT01497132