An interventional study of vitamin D in Vitamin D Deficiency and Central Sensitisation, sponsored by Marmara University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by Marmara University · Not applicable, Interventional, and Screening
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 93rd largest by 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 99th 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: 18 Years to 65 Years · female · 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 enrollment of 51 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:
Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Marmara 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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The purpose of this study is to investigate the presence of central sensitization in vitamin D deficiency and its effect on cutaneous silent period, pain, and quality of life. The secondary purpose of the study is to investigate whether a change in cutaneous silent period parameters, pain severity and neuropathic sensitization and quality of life after vitamin D replacement.
Vitamin D deficiency is a pandemia. Main causes of this is insufficient exposure to sunlight. Vitamin D deficiency is related to conditions like various cancers, autoimmune diseases, hypertension and growth retardation in children (1).
International Association for the study of pain has defined pain as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." (2). Pain lasting longer than 3 months has been deemed as chronic pain (3). Vitamin D deficiency influences various types of pain, including chronic pain (4,5,6,7).
Vitamin D influences the musculoskeletal system via the calcium-phosphorus metabolism and the receptors found in skeletal muscle cells (8). Vitamin D deficiency has been shown to decrease muscle strength, the this decrease in proximal muscles affect postural stability and can increase falls. Vitamin D deficiency also causes problems in bone mineralization, causing isolated or widespread pain in muscles, bones and joints. These patients end up getting wrong diagnoses such as fibromyalgia, osteoarthritis, inflammatory arthritis, and chronic fatigue syndrome (1,7). Vitamin D deficiency causes hyperinnervation and hypersensitivity on nerves and cause pain to be felt more intensely (5).
In a normal skeletal muscle, during an isometric contraction, a number of motor unit will be activated. These motor units produce a stable electromyography pattern and keep their own frequencies during contraction. If the nerve, tendon or a cutaneous nerve nearby is stimulated, electromyographic activity is disrupted and a bioelectric silence occurs. This is called cutaneous silent period (CSP). It is an inhibitory spinal reflex and its afferents consist of A-delta nerve fibers.
In various studies, CSP has been shown to be clinically beneficial in conditions like peripheral neuropathy, syringomyelia, Parkinson's disease, restless leg syndrome and fibromyalgia.
von Känel R et al. has investigated the effect of vitamin D deficiency on widespread pain index (WPI) and symptom severity score (SSS) and found out that it increases central sensitivity (8). In thei study, thy did not utilize any electrophysiologic objective measurements. Akyüz et al. have investigated the effect of vitamin D deficiency on chronic pain and nerve conduction studies; they have shown that vitamin D is correlated with various nerve conduction parameters while these parameters do not change after replacement (9,10).
Patients with vitamin D deficiency and healthy controls with normal vitamin D levels will be compared in terms of cutaneous silent period parameters, pain severity and neuropathic sensitization and quality of life. Cutaneous silent period parameters (duration and latency ), The Leeds Assessment of Neuropathic Symptoms \& Signs and Nottingham Health Profile will be used for the assessments. Patients with vitamin D deficiency will receive vitamin D supplementation therapy. Before and after therapy, cutaneous silent period parameters, LANSS scores and Nottingham Health Profile will measured before and 8 weeks after starting vitamin D supplementation therapy.
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.
Patients with vitamin D deficiency will receive vitamin D replacement therapy. Before and after therapy, cutaneous silent period will be measured from each upper extremity and latencies will be recorded. Their LANSS scores and Notthingham Health Profile will be recorded before and after treatment.
Dietary Supplement: vitamin D
Vitamin D replacement
cutaneous silent period latency (ms)
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve
Time frame: 8 weeks
cutaneous silent period duration (ms)
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve
Time frame: 8 weeks
Visual analog scale (VAS) of pain
line from 0: no pain to 10:worst pain
Time frame: 8 weeks
Leeds assessment of neuropathic symptoms and signs (LANSS)
Reduction of pain related to central sensitization. LANSS scale ⩾ 12 refers to "Neu- neuropathic sensitization"
Time frame: 8 weeks
The Nottingham Health Profile (NHP)
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.
Time frame: 8 weeks
Plan to share: No
Ran from Jan 2018 to primary completion in Dec 2018, 10 months.
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 10 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 completed, as verified in Dec 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