Study Vitamin D in Healthy Individuals
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/11/2015 |
| Start Date: | May 2014 |
| End Date: | June 2015 |
| Contact: | Alicia Sable-Hunt |
| Email: | Sablehunt@edwardshunt.com |
| Phone: | 203-768-9733 |
A Prospective Collection of Peripheral Blood Specimens to Study Vitamin D in Healthy Individuals
To obtain sufficient specimens and correlating clinical data from a well-controlled
prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays,
and to establish a collection of specimens that will support future assay discovery and
validation efforts.
prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays,
and to establish a collection of specimens that will support future assay discovery and
validation efforts.
1. Obtain matched serum and plasma specimens collected from a minimum of 50 healthy
subjects in two geographic areas. Specimens will be used to determine a reference
range for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency
in adults.
2. Obtain serum specimens collected from a minimum of an additional 450 healthy subjects
in two geographic areas. Specimens will be used to determine a reference range for a
vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults.
3. To store any remaining specimens for use in future vitamin D assay development and to
evaluate as yet undetermined assays for the development of IVDs, including additional
vitamin D assays
subjects in two geographic areas. Specimens will be used to determine a reference
range for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency
in adults.
2. Obtain serum specimens collected from a minimum of an additional 450 healthy subjects
in two geographic areas. Specimens will be used to determine a reference range for a
vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults.
3. To store any remaining specimens for use in future vitamin D assay development and to
evaluate as yet undetermined assays for the development of IVDs, including additional
vitamin D assays
Inclusion Criteria:
Males and females, age≥ 18 years Able to understand and willing to provide informed
consent
Exclusion Criteria:
Males and females, age <18 years Current use of dietary supplements (tablet, liquid gel or
liquid form only) containing high concentrations, greater than 2,000 IU per day, of
vitamin D.
Has a history of vitamin D deficiency Has a history or current diagnosis of any clinically
significant cardiac, respiratory, neurological, immunological, hematological, liver
disease, renal disease, gastrointestinal (GI) disorder, including any history of peptic or
gastric ulcers or GI bleeding, or any other condition which, in the opinion of the
investigator is considered chronic.
Personal history of seizures Personal history of bariatric surgery Personal history of
parathyroid and thyroid disease Pregnancy or lactation Is receiving systemic chemotherapy
or radiation treatment, has an active malignancy of any type, or has been diagnosed with
cancer within 5 years before screening other than basal or squamous cell skin cancers or
in-situ cervical cancer.
Family history of parathyroid or calcium regulatory disease Medications known to affect
absorption e.g. drugs that inhibit cholesterol absorption Medications known to increase
catabolism such as anticonvulsants, glucocorticoids, HAART (AIDS treatment) and
anti-rejection medications Unable to provide informed consent
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