A Phase 3 interventional study of Vitamin D and Placebo in Hypovitaminosis D, sponsored by University of Tromso. Completed at 1 site in Norway. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-24.
Sponsored by University of Tromso · Phase 3, Interventional, and Prevention
Among 154 studies testing Vitamin D in Vitamin D Deficiency — 15 open to participants now, 16 under way, none of them phase 3. Vitamin D · Vitamin D Deficiency.
Among the 154 studies testing Vitamin D in Vitamin D Deficiency, this one is the 86th largest by enrollment of the 153 interventional ones that give a count, is one of 11 that started in 2017, is one of 8 in phase 3, and was the 88th registered.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
Browse Vitamin D Deficiency studies →15 of the 154 studies testing Vitamin D in Vitamin D Deficiency are open now, in 8 countries. Recruiting first, the newest first:
Yale University · Sites in United States
Ages 13–21 · Women only
Future University in Egypt · Sites in Egypt
Ages 20–60 · Healthy volunteers
The Jerzy Kukuczka Academy of Physical Education in Katowice · Sites in Poland
Ages 17–60 · Healthy volunteers
Bangladesh Medical University · Sites in Bangladesh
Ages 51–70 · Men only
Bangladesh Medical University · Sites in Bangladesh
Ages 20–40 · Men only
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 20 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 16 · Phase 3 8 · Phase 4 27
First in 2001; this study’s year is marked. 11 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 61 is below the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Median enrollment 75 across the 153 interventional studies. Of the 113 that completed or were terminated, 17 (15%) have results posted.
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2 of 154 have an industry lead sponsor. The 10 most frequent:
University of Tromso is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
University of Tromso has 4 studies filed under Vitamin D Deficiency — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 154 studies testing Vitamin D in Vitamin D Deficiency, from their registry updates:
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Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes, cancer, infectious and immunological diseases, as well as risk factors for these diseases. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and short and underpowered studies. In addition, there are indications that the dosing regimens may be important, so that daily doses with vitamin D are more efficient than intermittent doses, which so far have been generally used. This could be related to the concentration of circulating and thereby intracellular vitamin D concentrations, which probably is dependent on daily vitamin D doses. This will be tested in the present study where 60 subjects will be randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks, with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and 24,25(OH)2D as secondary endpoints.
Inclusion Criteria:- Males and females 20 - 70 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
vitamin D 160 000 IU given as bolus
Drug: Vitamin D
vitamin D 4000 IU daily for 28 days
Drug: Vitamin D
identical looking as vitamin d
Drug: Placebo
vitamin D given as bolus versus daily dosing
identical looking as vitamin D
Hepcidin change
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
Time frame: 4 weeks
Difference in serum PTH after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum PTH, cathelicidin, RNA expression and micro RNA in peripheral blood, telomerase activity and the ratio between 1,25(OH)2D and 24,25(OH)2D, after 1 month
Time frame: 4 weeks
Difference in micro RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Difference in serum cathelicidin after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Difference in RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Difference in telomerase Activity after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Apr 2018, 4 months.
Of 18 phase 3 interventional studies under Vitamin D Deficiency, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D
University of Tromso