A Phase 1 interventional study of Vitamin D and Placebo in Deficiency, Vitamin D, sponsored by Universidade de Passo Fundo. Status unknown at 1 site in Brazil. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-29.
Sponsored by Universidade de Passo Fundo · Phase 1, 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 128th largest by planned enrollment of the 153 interventional ones that give a count, is one of 11 that started in 2017, is one of 16 in phase 1, and was the 90th 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: 25 Years to 75 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 planned enrollment of 20 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:
Universidade de Passo Fundo is the lead sponsor of 15 studies on the registry; none are open to participants now.
Universidade de Passo Fundo 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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This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled clinical trial. Background: Vitamin D replacement could aid in the osseointegration of dental implants. Objective: to evaluate the effect of vitamin D replacement on osseointegration of dental implants in humans. Materials and methods: Twenty individuals with hypovitaminosis D underwent dental miniimplants and randomized to two equal groups for treatment with vitamin D (5000 IU / day) or placebo for 2 months. After two months, the miniimplants will be removed and prepared for histomorphometric analysis, which will evaluate bone implant contact in percentage. Testing the hypothesis that the contact between bone and implant and the bone density in the threaded area in the test group is higher than in the control group. Test t will be used to compare the differences between the groups.
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:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin D 5.000 IU a day for 2 months (10 drops after lunch)
Drug: Vitamin D
Placebo for 2 months (10 drops after lunch)
Other: Placebo
Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This group will receive vitamin D supplementation. Vitamin D3 - cholecalciferol, oral suspension in drops, will be prescribed as follows: • 5,000 IU / day - 10 drops per day for two months.
Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This control group will receive placebo. Placebo (olive oil mint flavor), oral suspension in drops, will be prescribed as follows: • 10 drops per day for two months.
Percentage of bone implant contact
Histomorphometry will be used as a method of analysis. It will evaluate the initial stage of osseointegration in the two groups, relating it to insufficiency / deficiency and sufficiency of vitamin D. The percentage of bone implant contact, defined as the amount of mineralized bone in direct contact with the surface of the miniimplant, will be evaluated.
Time frame: 2 months
Serum levels of vitamin D (ng/ml)
The 25-hydroxyvitamin D test is a common blood test and is the best way to monitor vitamin D levels. The test can determine if the person's blood has deficiency or excessive vitamin D. The method used to evaluate the blood test is chemiluminescent immunoassay technology (CLIA).
Time frame: 2 months
Plan to share: Yes — The individual participants data (IPD) will be available in the dental records including complementary exams, allowing the access of other researchers during the research.
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Dec 2017, 1 month after the start.
Of 13 phase 1 interventional studies under Vitamin D Deficiency, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 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
Universidade de Passo Fundo