An interventional study of Vitamin D in Heart Failure With Reduced Ejection Fraction and Vitamin D Deficiency, sponsored by Linkoeping University. Status unknown at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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 17th largest by planned enrollment of the 153 interventional ones that give a count, is one of 10 that started in 2018, is one of 87 with no phase, and was the 91st 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: all sexes · no healthy volunteers.
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. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above 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:
Linkoeping University is the lead sponsor of 193 studies on the registry; 40 are open to participants now.
Linkoeping University has 1 study 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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In 200 patients with documented systolic heart failure give supplementation with vitamin D in those with a 25-OH- vitamin D \< 50nmol/L - or placebo.
In those with a vitamin D level \<25nmol/L a substitution of 2400IU will be given, and in those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given.
Intervention time 12 months. Biomarkers of heart function, quality of life, and hospitalisation will be analysed.
In a population with a systolic heart failure with an EF\<40%, the levels of vitamin D will be analysed. In those with a 25-OH-vitamin D level \<50nmol/L the patients that accept participation, will be randomised into active supplementation as described below, or placebo.
The intervention time will be 12 months. In the project 200 heart failure patients will be included. Blood samples including heart failure biomarkers, and biomarkers for inflammation and oxidative stress will be drawn at 3,6, 9 and 12 months.
Health related quality of life will be evaluated by use of Euro-QoL-5D Minnesota Living with Heart Failure.Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaire, as also hospitalisation during the project time.
Cardiac function according to echocardiography will be analysed at start, and study end.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In the group randomised to active treatment and with a screening level of 25-OH-vitamin D 25-50nmol/L an intervention with 1600IE daily of vitamin D will be given. In those randomised to active treatment and with a screening level of 25-OH-vitamin D of \<25nmol/L, an intervention of 2400IE of vitamin D will be given.
Dietary Supplement: Vitamin D
In the group randomised to placebo and with a screening level of 25-OH-vitamin D \<50 mol/L, the participants will be given placebo.
Dietary Supplement: Vitamin D
Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level\<50nmol/L at screening
Reduction in the composite endpoint for heart failure
Reduction in biomarkers for heart failure(Nt-proBNP, Copeptin, MR-proADM and Chromogranin A) and in hospitalisation that comprised the composite endpoint
Time frame: Follow-up 12 months after stop of intervention
Influence on quality of life in patients with heart failure by the intervention
Effect on health related quality of life as measured by the Euro-QoL-5D Minnesota Living with Heart Failure. Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaires
Time frame: Follow-up 12 months after stop of intervention
Influence on quality of life in patients with heart failure by the intervention
Effect on health related quality of life as measured by Minnesota Living with Heart Failure
Time frame: Follow-up 12 months after termination of the intervention
Influence on symptoms of depression in patients with heart failure by the intervention
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Follow-up 12 months after termination of intervention
Influence on perceived fatigue in patients with heart failure by the intervention
Effect on as measured using the Multidimensional Fatigue Inventory 20
Time frame: Follow-up 12 months after termination of the intervention
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Feb 2019, 12 months after the start.
Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's planned 12 months is close to that.
Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D