Evidence map›Paper›PMID 34984028›Full record

ArticleJournal of pain research2021

The Benefits of Add-on Therapy of Vitamin D 5000 IU to the Vitamin D Levels and Symptoms in Diabetic Neuropathy Patients: A Randomized Clinical Trial.

Rizaldy Taslim Pinzon, Vincent Ongko Wijaya, Vanessa Veronica

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04689958 (The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT04689958 phase2 / phase3unknown statusnot on this map

The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient: Randomized Clinical Trial

TypeinterventionalSponsorDuta Wacana Christian UniversityRan2020 to 2021Enrolled60ConditionsPainful Diabetic NeuropathyArmsStandard therapy, Vitamin D 5,000IU Oral Tablet
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Vitamin D in Neurological Diseases.International journal of molecular sciences · 2022
    Review
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

3 authors at 1 institution in 1 country.

Rizaldy Taslim PinzonFaculty of Medicine, Duta Wacana Christian University, Yogyakarta, Indonesia.ORCID 0000-0002-3357-9907
Vincent Ongko WijayaFaculty of Medicine, Duta Wacana Christian University, Yogyakarta, Indonesia.ORCID 0000-0001-7147-851X
Vanessa VeronicaFaculty of Medicine, Duta Wacana Christian University, Yogyakarta, Indonesia.ORCID 0000-0002-5568-3000
Duta Wacana Christian University · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies have demonstrated a significant relationship between vitamin D deficiency and the development of diabetic peripheral neuropathy (DPN). However, current studies are limited regarding the potential therapeutic benefits of vitamin D therapy in these patients.

objectiveThis study aimed to assess the effect of oral vitamin D supplementation in patients with diabetic peripheral neuropathy in addition to standard treatment.

methodsThis study was a controlled, open-label, randomized clinical trial with an active comparator randomly allocated with a 1:1 ratio. The experimental group received an add-on oral vitamin D 5000 IU once daily and standard treatment (pregabalin, gabapentin, or amitriptyline) over eight weeks. The control group received standard treatment alone. The measured outcomes were the change in the score of the visual analog scale (VAS), numerical rating scale (NRS), and brief pain inventory (BPI). Vitamin D levels were also measured before and after the trial.

resultsData from 68 subjects with DPN was collected and analyzed. Most of them (60.3%) were female, aged 64.96 ± 8.3 years. After eight weeks of treatment, the experimental group showed a more significant reduction of mean VAS (-3.34 ± 2.03 vs -2.37 ± 2.2, p=0.044) and burning pain (1.76 ± 7.16 vs 6.18 ± 13.93, p=0.046) scores compared to controls. Mood also improves better in the experimental group (88.2% vs 70.6%, p=0.031). At the end of the study, vitamin D levels were also improved more significantly in the experimental group (40.02 ± 15.33 ng/mL vs 18.73 ± 6.88 ng/mL; p<0.001) with greater changes from the baseline to week 8 (+24.14±13.68 ng/mL vs +3.10±4.20 ng/mL; p<0.001) compared to control group. The intervention group showed a negative correlation between vitamin D level and VAS score (r = -0.403, P = 0.018). There were no adverse events recorded in this study.

conclusionThe addition of oral vitamin D 5000 IU to standard treatment significantly improves pain, mood, and vitamin D levels more effectively than standard treatment alone in patients with diabetic neuropathy.

trial registrationClinicalTrials.gov.no NCT04689958.

Indexed as

diabetesdiabetic neuropathysupplementationvitamin D

Identifiers

PMID34984028
PMCPMC8699777
OpenAlexW4200073291

What OpenQuestion holds

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Registered trials

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 OpenQuestion graph.