Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000468527
Ethics application status
Approved
Date submitted
20/01/2024
Date registered
16/04/2024
Date last updated
16/04/2024
Date data sharing statement initially provided
16/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of dispersible vitamin D and B12 supplementation in vitamin D and B12 insufficiency
Scientific title
Effects of a novel dispersible supplement containing 2500IU of vitamin D and 1000µg of B12 in restoring vitamin D and B12 insufficiency
Secondary ID [1] 311379 0
Nill Known
Universal Trial Number (UTN)
U1111-1302-9227
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vitamin D deficiency 332648 0
vitaminB12 deficiency 332649 0
Condition category
Condition code
Diet and Nutrition 329355 329355 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized, three- arms controlled trial. Two interventional arms and one control arm. Patients with vitamin D and B12 insufficiency will be treated with cholecalciferol-containing supplements and vitamin b12 supplements, or a novel supplement containing both vitamin D and b12.
Participants will be randomized to treatment arms ( Arm1 and Arm2) or control group (Arm3) .
Arm 1: Novel supplement containing both vitamin D (2500IU) and b12 (1000mg), taken once daily for 90 days via oral dispersible tablets.
Arm 2: Two supplements: One dispersible oral tablet containing 1000mg of B12, daily for 90 days and one oral tablet containing 2000IU of vitamin D, daily for 90 days, after lunch.
Arm 3: No treatment, active surveillance
Compliance will be monitored via drug tablet return in the end of the study.
Intervention code [1] 327822 0
Treatment: Other
Comparator / control treatment
Control group will not receive any kind of treatment
Control group
Active

Outcomes
Primary outcome [1] 337175 0
Blood levels of vitamins B12
Timepoint [1] 337175 0
Baseline and at 90 days of treatment
Primary outcome [2] 337176 0
Blood levels of vitamin D
Timepoint [2] 337176 0
baseline and at 90 days of treatment
Secondary outcome [1] 430971 0
Adverse effects related to the specific used supplement ( eg: nausea, gastrointestinal symptoms, taste, kidney problems, allergic reactions)
Timepoint [1] 430971 0
Participants will be monitored for potential adverse effects every 30 days during the treatment period

Eligibility
Key inclusion criteria
Patients with serum vitamin d levels lower than 25 ng/dl and b12 levels lower than 250 ng/L
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.individuals who have been taking vitamin D supplements regularly or at high doses prior to the study.
2.Medications affecting vitamin D metabolism: Exclude individuals who are taking medications known to interfere with vitamin D metabolism or absorption, such as antiepileptic drugs (phenytoin, phenobarbital), glucocorticoids (prednisone), or certain weight-loss medications (orlistat).
3.Chronic kidney disease
4.Other metabolic disorders: individuals with specific metabolic disorders that could impact vitamin D metabolism or lead to altered vitamin D levels, such as primary hyperparathyroidism, hyperthyroidism, or malabsorption syndromes (e.g., celiac disease, Crohn's disease).
5.Conditions that significantly affect bone health, such as osteoporosis, osteomalacia, or Paget's disease.
6.Pregnancy and breastfeeding
7.Severe illnesses or comorbidities: terminal cancer, uncontrolled diabetes, or autoimmune disorders.
8. Drugs that affect vitamin b12 metabolism: Drugs
• Alcohol
• Nitrous oxide
• Proton pump inhibitors
• H2 receptor antagonists
• Metformin
• Colchicine
• Slow K (potassium chloride) preparations
• Cholestyramine
9. History of bariatric surgery and/or stomach operation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation via numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table generated by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome is the effect of serum levels of B12 and vitamin D. This will be assessed by intergroup comparison and by comparison of the two treated groups in the end of the study. All analysis will be performed at the completion of the trial. Participants who withdraw from the study will not be replaced.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
Date of last participant enrolment
Anticipated
30/05/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 26091 0
Greece
State/province [1] 26091 0

Funding & Sponsors
Funding source category [1] 315637 0
Commercial sector/Industry
Name [1] 315637 0
Geoplan Nutraceuticals
Country [1] 315637 0
Greece
Primary sponsor type
Individual
Name
Nicholaos Angelopoulos,MD,Phd
Address
venizelou 26G, Kavala, 65302
Country
Greece
Secondary sponsor category [1] 317738 0
None
Name [1] 317738 0
Address [1] 317738 0
Country [1] 317738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314521 0
Hellenic Endocrine Network Ethics Committee
Ethics committee address [1] 314521 0
Ethics committee country [1] 314521 0
Greece
Date submitted for ethics approval [1] 314521 0
02/01/2024
Approval date [1] 314521 0
17/01/2024
Ethics approval number [1] 314521 0
2024/0121311

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131878 0
Dr Nicholaos George Angelopoulos
Address 131878 0
Veniselou 26G, Kavala,65302,"EndoErgo",Endocrine Clinic
Country 131878 0
Greece
Phone 131878 0
+302510225200
Fax 131878 0
+302510830900
Email 131878 0
[email protected]
Contact person for public queries
Name 131879 0
Nicholaos George Angelopoulos
Address 131879 0
Veniselou 26G, Kavala,65302,"EndoErgo" , Endocrine Clinic
Country 131879 0
Greece
Phone 131879 0
+302510225200
Fax 131879 0
+302510830900
Email 131879 0
[email protected]
Contact person for scientific queries
Name 131880 0
Nicholaos George Angelopoulos
Address 131880 0
Veniselou 26G, Kavala,65302, "EndoErgo", Endocrine Clinic
Country 131880 0
Greece
Phone 131880 0
+302510225200
Fax 131880 0
+302510830900
Email 131880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (email: [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21449Informed consent form  [email protected]
21450Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.