UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056299 |
|---|---|
| Receipt number | R000064329 |
| Scientific Title | Effects of Vitamin D 3 supplement on the cognitive status in patient with Systemic lupus Erythematosus with neuropsychiatric phenomenon. |
| Date of disclosure of the study information | 2024/11/28 |
| Last modified on | 2024/11/28 17:28:13 |
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Basic information
Public title
Effects of Vitamin D 3 supplement on the cognitive status in patient with Systemic lupus Erythematosus with neuropsychiatric phenomenon.
Acronym
Effects of Vitamin D 3 supplement on the cognitive status in patient with Systemic lupus Erythematosus with neuropsychiatric phenomenon. NPSLE Vit D
Scientific Title
Effects of Vitamin D 3 supplement on the cognitive status in patient with Systemic lupus Erythematosus with neuropsychiatric phenomenon.
Scientific Title:Acronym
Effects of Vitamin D 3 supplement on the cognitive status in patient with Systemic lupus Erythematosus with neuropsychiatric phenomenon. NPSLE Brain SPECT Vit D
Region
| Asia(except Japan) |
Condition
Condition
While Vitamin D insufficiency is found to be associated with cognitive impairment in adults, the SLE itself is found to be associated with cognitive dysfunction (NPSLE) in about 39% [Semin Arthritis Rheum 2018;48(2):240-255] and with vitamin D insufficiency in about 16-95% affected adults. While the association of vitamin D insufficiency and NPSLE remains unknown, no reported data suggests that correction of vitamin D insufficiency can halt cognitive deterioration or facilitate cognitive improvement of NPSLE in adults. The proposed study aims to investigate association of insufficiencies of vitamin D-3, through quantitative assay in NPSLE patients whose diagnoses is to be confirmed with serum auto antibodies' assay and BRAIN SPECT perfusion scan and then the study shall continue to observe short term clinical outcome after a supplementation of vitamin D.
Classification by specialty
| Endocrinology and Metabolism | Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Vitamin D3 supplementation on the cognitive status in SLE patients with neuropsychiatric phenomena.
Basic objectives2
Others
Basic objectives -Others
collect socio-demographic data of the participants
analysis of anti-ds-DNA and anti-phospholipid antibody
determine baseline serum Vitamin D status
assess the baseline cognitive impairment status by Neuropsychological tests (NP tests) with MMSE (mini mental state examination)
find out the area of brain perfusion deficit by brain SPECT imaging
evaluate Z score for severity of cognitive impairment
evaluate the effect of Vitamin D3 intervention on cognitive function after 6 months, by endline serum Vitamin D status, MMSE and brain SPECT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vitamin D3 supplementation led to substantial improvements in serum vitamin D levels, cognitive function (MMSE scores), and brain perfusion in the intervention group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
vitamin D supplementation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Confirmed diagnosed cases of NPSLE (according to American College of Rheumatology Guideline) along with low vitamin D status.
Key exclusion criteria
Exclusion Criteria
Current use of vitamin D3 or calcium supplement.
Current or past diagnosis of cognitive impairment or dementia due to known brain disorders
Use of certain drugs such as corticosteroid, hormone replacement, psychoactive drugs
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Nasreen |
| Middle name | |
| Last name | Sultana |
Organization
National Institute of Nuclear Medicine & Allied Sciences(NINMAS)
Division name
Dhaka
Zip code
1000
Address
Room No: 805, 7th Floor Block D, NINMAS, BSMMU .Dhaka
TEL
+8801711481442
nasreeninm@yahoo.com
Public contact
Name of contact person
| 1st name | Nasreen |
| Middle name | |
| Last name | Sultana |
Organization
National Institute of Nuclear Medicine & Allied Sciences(NINMAS)
Division name
Dhaka
Zip code
1000
Address
Room No: 805, 7th Floor Block D, NINMAS, BSMMU .Dhaka
TEL
+8801711481442
Homepage URL
nasreeninm@yahoo.com
Sponsor or person
Institute
National Institute of Nuclear Medicine & Allied Sciences(NINMAS)
Institute
Department
Personal name
Funding Source
Organization
National Institute of Nuclear Medicine & Allied Sciences(NINMAS)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Biological science department of University of Dhaka.Reference No : 119/Biol. Scs. February 04, 2021.
Address
Suhrawardi Udyan road , Dhaka
Tel
+8801729920381
msaidularefindmc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064329
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