Evidence mapPaperPMID 33513879Full record

Trial reportNutrients2021

Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Trial.

Triantafyllos Didangelos, Eleni Karlafti, Evangelia Kotzakioulafi, Eleni Margariti, Parthena Giannoulaki, Georgios Batanis, Solomon Tesfaye, Kοnstantinos Kantartzis

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 4 pooled it
15.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 4 syntheses or guidelines pooled it, 142 citations in OpenAlex.

  1. Pooled it
  2. Micronutrient status of patients with diabetic foot: A systematic review.Asia Pacific journal of clinical nutrition · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article

3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Triantafyllos DidangelosDiabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, "AHEPA" Hospital, Aristotle University of Thessaloniki, 54621 Thessaloniki, Greece.
Eleni KarlaftiDiabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, "AHEPA" Hospital, Aristotle University of Thessaloniki, 54621 Thessaloniki, Greece.
Evangelia KotzakioulafiDiabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, "AHEPA" Hospital, Aristotle University of Thessaloniki, 54621 Thessaloniki, Greece.ORCID 0000-0003-4841-1928
Eleni MargaritiDiabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, "AHEPA" Hospital, Aristotle University of Thessaloniki, 54621 Thessaloniki, Greece.
Parthena GiannoulakiDepartment of Nutrition and Dietetics, University General Hospital of Thessaloniki ''AHEPA'', 54621 Thessaloniki, Greece.ORCID 0000-0002-9413-6368
Georgios BatanisDiabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, "AHEPA" Hospital, Aristotle University of Thessaloniki, 54621 Thessaloniki, Greece.
Solomon TesfayeDiabetes Research Unit, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield S10 2JF, UK.
Kοnstantinos KantartzisDepartment of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University of Tübingen, 72076 Tübingen, Germany.ORCID 0000-0002-0584-1138
Aristotle University of Thessaloniki · GRAHEPA University Hospital · GRDeutsches Diabetes-Zentrum e.V. · DERoyal Hallamshire Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo investigate the effect of normalizing vitamin B12 (B12) levels with oral B12 (methylcobalamin) 1000 μg/day for one year in patients with diabetic neuropathy (DN). PATIENTS AND

methodsIn this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin for at least four years and both peripheral and autonomic DN were randomized to an active treatment group (n = 44) receiving B12 and a control group (n = 46) receiving a placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurements of sural nerve conduction velocity (SNCV), sural nerve action potential (amplitude) (SNAP), and vibration perception threshold (VPT), and they performed cardiovascular autonomic reflex tests (CARTs: mean circular resultant (MCR), Valsalva test, postural index, and orthostatic hypotension). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF, respectively). We also used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively) and questionnaires to evaluate quality of life (QoL) and level of pain (pain score).

resultsB12 levels increased from 232.0 ± 71.8 at baseline to 776.7 ± 242.3 pmol/L at follow-up,

conclusionsThe treatment of patients with DN with 1 mg of oral methylcobalamin for twelve months increased plasma B12 levels and improved all neurophysiological parameters, sudomotor function, pain score, and QoL, but it did not improve CARTS and MNSIE.

Indexed as

Dietary SupplementsCholesterolCreatinineDiabetes Mellitus, Type 2Diabetic NeuropathiesDouble-Blind MethodFemaleFolic AcidFollow-Up StudiesGlycated HemoglobinHumansHypoglycemic AgentsLinear ModelsMaleMiddle AgedProspective StudiesCholesterolCreatinineFolic AcidGlycated HemoglobinHypoglycemic AgentsmecobalaminTriglyceridesVitamin B 12autonomic neuropathydiabetes mellitusdiabetic footdiabetic neuropathymetforminpainful neuropathySUDOSCANvitamin B12

Identifiers

PMID33513879
PMCPMC7912007
OpenAlexW3121203051

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.