Evidence map›Paper›PMID 26151178›Full record

Trial reportNutrients2015

A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency.

Marie-Louise Schleck, Jean-Claude Souberbielle, Bernard Jandrain, Stéphanie Da Silva, Sophie De Niet, Francis Vanderbist, André Scheen, Etienne Cavalier

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02936999 (An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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.

NCT02936999 early_phase1terminatednot on this mapstarted 2016, after this paper: background citation

An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS

TypeinterventionalSponsorInova Health Care ServicesRan2016 to 2019Enrolled8ConditionsBreast CancerArmsCholecalciferol
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Calcifediol Is Not Superior to Cholecalciferol in Improving Vitamin D Status in Postmenopausal Women.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Article
  9. Review
  10. 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.

Marie-Louise SchleckDepartment of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège B-4000, Belgium. mlschleck@chu.ulg.ac.be.
Jean-Claude SouberbielleLaboratoire d'Explorations fonctionnelles, Hôpital Necker-Enfants malades, Paris 75015, France. jean-claude.souberbielle@nck.aphp.fr.
Bernard JandrainDepartment of Clinical Pharmacology, ATC SA, Liège B-4000, Belgium. Bernard.jandrain@atc-pharma.com.
Stéphanie Da SilvaClinical Department, Laboratoires SMB SA, Brussels 1080, Belgium. sdsil@smb.be.
Sophie De NietClinical Department, Laboratoires SMB SA, Brussels 1080, Belgium. sdeni@smb.be.
Francis VanderbistClinical Department, Laboratoires SMB SA, Brussels 1080, Belgium. fvdbi@smb.be.
André ScheenDivision of Diabetes, Nutrition and Metabolic Disorders, CHU Sart Tilman, University of Liège, Liège B-4000, Belgium. andre.scheen@chu.ulg.ac.be.
Etienne CavalierDepartment of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège B-4000, Belgium. Etienne.cavalier@chu.ulg.ac.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many people worldwide are vitamin D (VTD) deficient or insufficient, and there is still no consensus on the dose of VTD that should be administered to achieve a 25(OH)D concentration of 20 or 30 ng/mL. In this study, we aimed to determine an adapted supplementation of VTD able to quickly and safely increase the vitamin D status of healthy adults with low 25(OH)D. One hundred and fifty (150) subjects were randomized into three groups, each to receive, orally, a loading dose of 50,000, 100,000 or 200,000 IU of VTD3 at Week 0, followed by 25,000, 50,000 or 100,000 IU at Week 4 and Week 8. Whereas 25(OH)D baseline values were not different between groups (p = 0.42), a significant increase was observed at Week 12 (p < 0.0001) with a mean change from baseline of 7.72 ± 5.08, 13.3 ± 5.88 and 20.12 ± 7.79 ng/mL. A plateau was reached after eight weeks. No related adverse event was recorded. This study demonstrated a linear dose-response relationship with an increase in 25(OH)D levels proportional to the dose administered. In conclusion, a loading dose of 200,000 IU VTD3 followed by a monthly dose of 100,000 IU is the best dosing schedule to quickly and safely correct the VTD status.

Indexed as

AdolescentAdultCholecalciferolDietary SupplementsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedVitamin DVitamin D DeficiencyVitaminsYoung Adult25-hydroxyvitamin DCholecalciferolVitamin DVitaminsrandomized double-blind trialsafetyvitamin D

Identifiers

PMID26151178
PMCPMC4517004

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.