Serum 25(OH)D Concentration Clinical Trial
— VitDHiDOfficial title:
Comparing the Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 Treatment on Changes of the Transcriptome of Low Vitamin D Responders
NCT number | NCT03537027 |
Other study ID # | VitDHiD |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 3, 2018 |
Est. completion date | May 31, 2018 |
Verified date | October 2018 |
Source | University of Eastern Finland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to investigate in vivo whether a high-dose vitamin D3 oral bolus (2000 micrograms) produces marked vitamin D receptor target gene expression response and whether there is large inter-individual variation. These effects are compared to in vitro treatment of peripheral blood mononuclear cells from these subjects with 25(OH)D.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Non-smoking - BMI 20-25 kg/m2. Exclusion Criteria: - History of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or Wegener's granulomatosis. - Continuous use of anti-inflammatory medicines. - Regular use of supplements containing over 20 micrograms of vitamin D. |
Country | Name | City | State |
---|---|---|---|
Finland | University of Eastern Finland | Kuopio |
Lead Sponsor | Collaborator |
---|---|
University of Eastern Finland | DSM Nutritional Products, Inc. |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In vivo change from baseline in vitamin D target gene expression in the subjects | Effect of 2000 microgram vitamin D3 dose on the expression of vitamin D receptor target genes | 24 hours after the baseline | |
Primary | In vitro change from baseline in vitamin D target gene expression in peripheral blood mononuclear cells | Effects of treatment of cells for 24 h with 100 nM of 25(OH)D3, 1 nM of 1,25(OH)2D3 or vehicle (solvent) on the expression of vitamin D receptor target genes | 24 hours after the baseline | |
Secondary | In vivo change from baseline in serum 25(OH)D concentration | Effect of 2000 microgram vitamin D3 dose on serum 25(OH)D3 concentrations | 24 hours after the baseline | |
Secondary | In vivo change from baseline in serum calcium concentration (safety and tolerability) | Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum calcium concentrations | 24 hours after the baseline | |
Secondary | In vivo change from baseline in serum alanine transaminase concentration (safety and tolerability) | Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum alanine transaminase (ALAT) concentrations | 24 hours after the baseline | |
Secondary | In vivo change from baseline in serum gamma-glutamyl transferase concentration (safety and tolerability) | Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum gamma-glutamyl transferase (GGT) concentrations | 24 hours after the baseline | |
Secondary | In vivo change from baseline in serum creatinine concentration (safety and tolerability) | Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum creatinine concentrations | 24 hours after the baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02063334 -
The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25(OH)D3 and Vitamin D Receptor Target Gene Expression
|
Phase 1 |