Study Results
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View full resultsBasic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2008-10-01
2023-06-08
Brief Summary
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Detailed Description
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1. Time to plateau vitamin D concentrations after initiating vitamin D supplements
2. Safety of vitamin D replacement based on serum and urine calcium
3. Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone
4. Effect of vitamin D on markers of insulin resistance and inflammation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard vitamin treatment
10,000 I.U. of vitamin D3 weekly
Standard vitamin D3 treatment
10,000 I.U./wk of vitamin D3 orally for 6 months
50,000 I.U. of vitamin D3
50,000 I.U. of vitamin D3 weekly
High dose vitamin D3 treatment
50,000 I.U./wk of vitamin D3 orally for 6 months
Interventions
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Standard vitamin D3 treatment
10,000 I.U./wk of vitamin D3 orally for 6 months
High dose vitamin D3 treatment
50,000 I.U./wk of vitamin D3 orally for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 19 years or older
* 25-hydroxy vitamin D ≤35 ng/ml
Exclusion Criteria
* Previous small bowel or lung transplant
* Pancreas transplant less than 6 months ago
* Cancer or any condition that would change their weight dramatically in the near future such as malabsorption
* Willing to return for testing every two months
* Women who are pregnant or \< 6 weeks postpartum
* Calcium \> 10.5 mg/dl
* Phosphate \> 4.8 mg/dl
* Drinking more than 2 alcohol drinks a day or 14 drinks per week
* History of parathyroid surgery
* Known granulomatous disease
* Taking any seizure medication that affects vitamin D
* Taking Zemplar ® and/or Rocaltrol ®
* History of kidney stones in the past 20 years
* Not on a stable dose of bisphosphonate for the past three months
* Planning on a pancreas transplant within the next year
* In any other research study
19 Years
ALL
No
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Jennifer L Larsen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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0382-08-FB
Identifier Type: -
Identifier Source: org_study_id
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