Evidence map›Paper›PMID 25166750›Full record

Trial reportPloS one2014

Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial.

Birgitte Nygaard, Niels Erik Frandsen, Lisbet Brandi, Knud Rasmussen, Ove Vyff Oestergaard, Lars Oedum, Hans Christian Hoeck, Ditte Hansen

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00952562 (The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT00952562 nacompletednot on this map

The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.

TypeinterventionalSponsorZealand University HospitalRan2009 to 2011Enrolled40ConditionsHealthyArmscholecalciferol, placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Oral vitamin DOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Pooled it
  3. Pooled it
  4. Trial
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  6. A Controlled Increase in Dietary Phosphate Elevates BP in Healthy Human Subjects.Journal of the American Society of Nephrology : JASN · 2018
    Trial
  7. Trial
  8. Article
  9. Article
  10. Article
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  12. Article
  13. CUA guideline on the evaluation and medical management of the kidney stone patient - 2016 update.Canadian Urological Association journal = Journal de l'Association des urologues du Canada
    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

8 authors.

Birgitte NygaardDepartment of Medicine, Roskilde University Hospital, Roskilde, Denmark.
Niels Erik FrandsenDepartment of Medicine, Roskilde University Hospital, Roskilde, Denmark.
Lisbet BrandiDepartment of Medicine, Roskilde University Hospital, Roskilde, Denmark.
Knud RasmussenDepartment of Medicine, Roskilde University Hospital, Roskilde, Denmark.
Ove Vyff OestergaardDepartment of Medicine, Roskilde University Hospital, Roskilde, Denmark.
Lars OedumDepartment of Clinical Biochemistry, Roskilde University Hospital, Roskilde, Denmark.
Hans Christian HoeckCenter for Clinical and Basic Research, Aalborg, Denmark.
Ditte HansenDepartment of Medicine, Roskilde University Hospital, Roskilde, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects. The safety, especially concerning changes in urinary calcium excretion is of great importance.

methodsIn a double-blinded, placebo-controlled study in 40 healthy volunteers, we examined the changes in mineral metabolism during supplementation with 3000 IU of oral cholecalciferol daily during 4 months.

resultsBoth 25(OH)vitamin D and 1,25(OH)2vitamin D increased significantly in the active treated group as compared to the placebo group (186% versus 14% (P<0.001) and 28% versus -8% (P<0.001)). No change was observed in urinary calcium excretion in the active group compared to the placebo group (P = 0.891). Fibroblast growth factor 23 increased significantly by 10% (P<0.018) in the active group. However, there was no difference in changes in FGF23 between treatment groups (P = 0.457).

conclusionHigh dose cholecalciferol significantly increases 25(OH)vitamin D and 1,25(OH)2vitamin D levels compared to placebo. No changes in urinary calcium excretion or other measured components of the mineral metabolism were found between groups.

trial registrationClinicalTrials.gov NCT00952562.

Indexed as

AdultCalciumCholecalciferolDouble-Blind MethodFemaleFibroblast Growth Factor-23Fibroblast Growth FactorsHealthy VolunteersHumansMaleMiddle AgedVitamin DVitamins1,25-dihydroxyvitamin D25-hydroxyvitamin DCalciumCholecalciferolFGF23 protein, humanFibroblast Growth Factor-23Fibroblast Growth FactorsVitamin DVitamins

Identifiers

PMID25166750
PMCPMC4148309

What OpenQuestion holds

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LicenceCC BY
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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.