Evidence map›Paper›PMID 35458137›Full record

ArticleNutrients2022

Safety Data in Patients with Autoimmune Diseases during Treatment with High Doses of Vitamin D3 According to the "Coimbra Protocol".

Ulrich Amon, Raul Yaguboglu, Madeleine Ennis, Michael F Holick, Julian Amon

Open access · goldAbstract read
In one paragraph

Article in Nutrients, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 6% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
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

5 authors at 2 institutions in 2 countries.

Ulrich AmonInternational Centre for Skin Diseases DermAllegra, Coimbra Protocol Certified Center, Am Markgrafenpark 6, 91224 Pommelsbrunn-Hohenstadt, Germany.ORCID 0000-0001-5230-7563
Raul YagubogluInternational Centre for Skin Diseases DermAllegra, Coimbra Protocol Certified Center, Am Markgrafenpark 6, 91224 Pommelsbrunn-Hohenstadt, Germany.
Madeleine EnnisThe Wellcome-Wolfson Institute for Experimental Medicine, Queens University of Belfast, Belfast BT7 1NN, UK.
Michael F HolickEndocrinology, Diabetes, Nutrition & Weight Management, Department of Medicine, Boston University School of Medicine, Boston, MA 02118, USA.ORCID 0000-0001-6023-9062
Julian AmonInternational Centre for Skin Diseases DermAllegra, Coimbra Protocol Certified Center, Am Markgrafenpark 6, 91224 Pommelsbrunn-Hohenstadt, Germany.ORCID 0000-0002-1677-8349
Boston University · USQueen's University Belfast · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 2013, the group of Cicero Coimbra, Brazil, reported the clinical efficacy of high doses of vitamin D3 in patients suffering from autoimmune skin disorders ("Coimbra protocol", CP). However, hypercalcemia and the subsequent impaired renal function may be major concerns raised against this protocol.

methodsWe report for the first time for a broad spectrum of autoimmune diseases in 319 patients (mean age (±SD) 43.3 ± 14.6 years, 65.5% female, 34.5% male) safety data for high doses of orally applied vitamin D3 (treatment period: up to 3.5 years) accompanied by a strict low-calcium diet and regular daily fluid intake of at least 2.5 L.

resultsMean vitamin D3 dose was 35,291 ± 21,791 IU per day. The measurement of more than 6100 single relevant laboratory parameters showed all mean values (±SD) within the normal range for total serum calcium (2.4 ± 0.1 mmol/L), serum creatinine (0.8 ± 0.2 mg/dL), serum creatinine associated estimated GFR (92.5 ± 17.3 mL/min), serum cystatin C (0.88 ± 0.19 mg/L), serum TSH (1.8 ± 1 mIU/L), and for 24 h urinary calcium secretion (6.9 ± 3.3 mmol/24 h). We found a very weak relationship between the dosage of oral vitamin D3 and the subsequent calcium levels, both in serum and in urinary excretion over 24 h, respectively.

conclusionsOur data show the reliable safety of the CP in autoimmune patients under appropriate supervision by experienced physicians.

Indexed as

Autoimmune DiseasesCholecalciferolVitamin DAdultBrazilCalciumCreatinineFemaleHumansMaleMiddle AgedParathyroid HormoneCalciumCholecalciferolCreatinineParathyroid HormoneVitamin Dautoimmune diseasesCoimbra protocolhigh-dose therapymultiple sclerosisparathyroid hormone (PTH)safetysingle nucleotide polymorphisms (SNPs)vitamin Dvitamin D receptor (VDR)vitiligo

Identifiers

PMID35458137
PMCPMC9033096
OpenAlexW4223565262

What OpenQuestion 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 OpenQuestion graph.