Gene Expression, Metabolomic, Microbiome, and Calcium Metabolism in Response to Varied Vitamin D Dosages
Completed · Not applicable
Conditions studied: Vitamin D Insufficiency
In brief
There continues to be debate as to how much vitamin D an adult requires to be vitamin D sufficient. A multitude of association studies have suggested that improving serum 25(OH)D \>30 ng/mL may reduce risk of many chronic illnesses and improve immune function. The aim of this study is to define dynamic changes in PTH, broad gene expression in circulating immune cells, metabolomics, and microbiome profile in response to varying doses of vitamin D supplementation.
Key facts
- Study ID
- NCT02856776
- Run by
- Boston University
- People needed
- 39
- Starts
- 2017-12-01
- Expected to finish
- 2018-08-06
- Last updated by the study team
- 2019-07-18
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or female adults
- Age 18-50 years
- BMI <30
- 25-hydroxyvitamin D < 29 ng/mL
- No medications or disorders that would affect vitamin D metabolism
- Women must be on birth control and not pregnant based on a negative pregnancy test at baseline
- Ability and willingness to give informed consent and comply with protocol requirements
You may not qualify if…
- Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogues
- Pregnancy
- History of elevated serum calcium (>10.6 mg%); that is corrected for albumin concentration
- Chronic hepatic or renal failure
- Supplementation with over the counter formulations of vitamin D2 or vitamin D3
- Subjects with a history of an adverse reaction to orally administered vitamin D.
- Subjects who are taking oral Dilantin or glucocorticoids.
- History of intestinal malabsorption (i.e. cystic fibrosis, fat malabsorption syndrome, Crohn's Disease, gastric bypass surgery).
- Inability to give informed consent
- Vacation plans to warmer climates (Florida, Southern CA, tropics) during study participation
- Subjects with any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
Where it is running
- Boston University Medical Campus — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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