AzTrials
AzTrials

Diabetes MellitusNCT04706377

Vitamin B12 Supplementation in Diabetic Neuropathy

A study testing B12 fix 1000mcg in people with Diabetes Mellitus and Diabetic Neuropathies, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This prospective double-blind placebo-controlled trial aims to investigate the safety and efficacy of oral dispersible tablet of vitamin B12 for 1 year, in 90 patients with diabetes mellitus type 2 and neuropathy. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
B12 fix 1000mcg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteGreece
Study dates
1 Feb 2018to 28 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults (>18 years old) with Diabetes Mellitus 2
  • established Diabetic neuropathy, both peripheral and autonomic (Diabetic Peripheral Neuropathy and Diabetic Autonomic Neuropathy). (Diagnosis was made with a)two or more Cardiovascular Autonomic Reflex Tests abnormal, b)abnormal nerve conduction velocity, c)abnormal Michigan Neuropathy Screening Instrument Questionnaire and Michigan Neuropathy Screening Instrument Examination ).
  • good glycemic control (HbA1c between 6.5 and 7.5 %), stable in the last year before participating in the study
  • metformin treatment for at least 4 years
  • low vitamin B12 levels according to suggested normal values for DM2 patients over 60 years old (<400 pmol/L)

Who cannot join

  • pernicious anemia,
  • alcoholism
  • gastrectomy
  • gastric bypass surgery
  • pancreatic insufficiency
  • malabsorption syndromes
Show all 12Show fewer
  • chronic giardiasis
  • acute infection in the last 6 months
  • cardiovascular event in the last 6 months
  • surgery involving small intestine or Human Immunodeficiency Virus infection.
  • Patients with estimated Glomerular Filtration Rate <50 mL/min/1.73m2
  • taking multivitamins or B12 supplements in the last 12 months

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • University General Hospital AHEPA

    Thessaloniki, Thessaloniki, 54621

Other trials in Greece

About this study

Official title: Vitamin B12 Supplementation in Diabetic Neuropathy :1-year Double Blind Randomized Placebo-Controlled Trial

This prospective double-blind placebo-controlled trial aims to investigate the safety and efficacy of oral dispersible tablet of vitamin B12 for 1 year, in 90 patients with diabetes mellitus type 2 and neuropathy.

Read the detailed description

In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin treatment for at least four years, and both peripheral and autonomic diabetic neuropathy were randomized to an active treatment group (n=44) receiving B12, and a control group (n=46) receiving placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurement of sural nerve conduction velocity and amplitude, vibration perception threshold, and performed cardiovascular autonomic reflex tests (CARTs: Mean Circular Resultant, Valsalva test, postural index and orthostatic hypotension]). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet. The Michigan Neuropathy Screening Instrument Questionnaire and Examination and questionnaires to evaluate quality of life and level of pain were also used.

Being tested
B12 fix 1000mcg, Placebo
Keywords
diabetic neuropathy, vitamin B12, SUDOSCAN, metformin, diabetic foot, Diabetes Mellitus, autonomic neuropathy, peripheral neuropathy, painful neuropathy
Medical subject headings
Diabetes Mellitus, Diabetic Neuropathies, Diabetes Complications, Diabetic Foot, Peripheral Nervous System Diseases, Neuropathy, Painful

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B12 fix 1000mcgDietary supplement

    Also called vitamin B12

    oral dispersible tablet with vitamin B12 1000mcg

  • PlaceboOther

    Placebo tablet

Study groups in NCT04706377
Study groupRoleWhat they receive
Active treatment groupActive comparatorPatients were given oral dispersible tablet with 1000μg of vitamin B12 daily for 12 months.
Receives: Dietary Supplement: B12 fix 1000mcg
Placebo groupPlacebo comparatorPatients were given placebo tablet similar to the tablet given to the active group once a day for 12 months.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Sural Nerve Function measured by conduction velocity

    Sural Nerve conduction velocity measured as m/s

    Measured: 12 months

  2. Change in Sural Nerve Function measured by amplitude

    Sural Nerve conduction amplitude measured as μV

    Measured: 12 months

  3. Change in Michigan Neuropathy Screening Instrument Questionnaire

    Michigan Neuropathy Screening Instrument questionnaire (The Michigan Neuropathy Screening Instrument (MNSI) includes two separate assessments, a 15-item self-administered questionnaire and a lower extremity examination. the questionnaire is scored by summing abnormal responses. Responses are added to obtain a total score. 'Yes' responses to questions 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. 'No' responses to questions 7 and 13 each count as one point. Question 4 was considered to be a measure of impaired circulation and question 10 a measure of general asthenia and were not included in the published scoring algorithm. A score of ≥ 7 was considered abnormal.

    Measured: 12 months

  4. Change in Michigan Neuropathy Screening Instrument Examination

    Michigan Neuropathy Screening Instrument Examination (The Michigan Neuropathy Screening Instrument (MNSI) includes two separate assessments, a 15-item self-administered questionnaire that is scored by summing abnormal responses, and a lower extremity examination that includes inspection and assessment of vibratory sensation and ankle reflexes and is scored by assigning points for abnormal findings.A score ≥ 2 was considered abnormal. Abnormality in each item is graded between 0.5 and 1 and at least more than 2 abnormal items are needed to reach the score of neuropathy. )

    Measured: 12 months

  5. Change in Electrochemical Skin Conductance

    Electrochemical Skin Conductance in hands and feet measured by SUDOSCAN

    Measured: 12 months

  6. Change in Cardiovascular Autonomic Reflex Tests (CARTs)

    CARTs were performed with Autonomic Nervous System Reader and included R-R variation during deep breathing [Mean Circular Resultant , Valsalva maneuver , 30:15 ratio expressed as postural index, and blood pressure response to standing (orthostatic hypotension)

    Measured: 12 months

  7. Change in Vibration perception threshold

    Vibration perception threshold was measured using a Biothesiometer

    Measured: 12 months

  8. Change in level of pain with painDETECT questionnaire

    painDETECT questionnaire consists of seven questions that address the quality of neuropathic pain symptoms; it is completed by the patient and no physical examination is required. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of ≤ 12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of ≥ 19 suggests that pain is likely to have a neuropathic component (> 90%). A score between these values indicates that the result is uncertain and a more detailed examination is required.

    Measured: 12 months

  9. Change in quality of life score

    Diabetes Quality of Life Brief Clinical Inventory (ThE DQOL questionnaire we used is a 15-items, brief-focused version of the Diabetes Quality of Life (DQOL) questionnaire developed in the DCCT and lowest score means worse quality of life whereas higher values indicate better quality of life)

    Measured: 12 months

  10. serum vitamin B12 levels

    serum vitamin B12 levels

    Measured: 12 months

Secondary outcomes (1)

  1. Adverse events

    report of any adverse events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start1 Feb 2018
  3. Primary completion28 Feb 2020
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double Blind Placebo Controlled Randomized Clinical Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706377
Sponsor's protocol ID
No42439
Status last verified
Jan 2021
First submitted
9 Jan 2021
Last updated
12 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing B12 fix 1000mcg in people with Diabetes Mellitus and Diabetic Neuropathies, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sural Nerve Function measured by conduction velocity (time frame: 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706377.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in