Evidence map›Paper›PMID 27986983›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2017

Optimum dose of vitamin D for disease prevention in older people: BEST-D trial of vitamin D in primary care.

H Hin, J Tomson, C Newman, R Kurien, M Lay, J Cox, J Sayer, M Hill, J Emberson, J Armitage and 1 more

Erratum issuedOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 41 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 18 pooled it
6.9field-weighted citation impact, top 2% 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

41 citing papers in PubMed, 18 syntheses or guidelines pooled it, 75 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

H HinHightown Surgery, Banbury, Oxfordshire, UK.
J TomsonClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
C NewmanDepartment of Medicine, Division of Endocrinology and Metabolism, New York University Langone Medical Center, New York, NY, USA.
R KurienClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
M LayClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
J CoxClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
J SayerClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
M HillClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
J EmbersonClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
J ArmitageClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
R ClarkeClinical Trial Service Unit (CTSU) and Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK. robert.clarke@ndph.ox.ac.uk.
MRC Epidemiology Unit · GBUniversity of Oxford · GBHighbury Hospital · GBNYU Langone Health · US

Funding

British Heart Foundation PG/12/32/29544Cancer Research UKMedical Research Council MC_UU_12026/5
6 · The paper itself

Abstract

This trial compared the effects of daily treatment with vitamin D or placebo for 1 year on blood tests of vitamin D status. The results demonstrated that daily 4000 IU vitamin D3 is required to achieve blood levels associated with lowest disease risks, and this dose should be tested in future trials for fracture prevention.

introductionThe aim of this trial was to assess the effects of daily supplementation with vitamin D3 4000 IU (100 μg), 2000 IU (50 μg) or placebo for 1 year on biochemical markers of vitamin D status in preparation for a large trial for prevention of fractures and other outcomes.

methodsThis is a randomized placebo-controlled trial in 305 community-dwelling people aged 65 years or older in Oxfordshire, UK. Outcomes included biochemical markers of vitamin D status (plasma 25-hydroxy-vitamin D [25[OH]D], parathyroid hormone [PTH], calcium and alkaline phosphatase), cardiovascular risk factors and tests of physical function.

resultsMean (SD) plasma 25(OH)D levels were 50 (18) nmol/L at baseline and increased to 137 (39), 102 (25) and 53 (16) nmol/L after 12 months in those allocated 4000 IU, 2000 IU or placebo, respectively (with 88%, 70% and 1% of these groups achieving the pre-specified level of >90 nmol/L). Neither dose of vitamin D3 was associated with significant deviation outside the normal range of PTH or albumin-corrected calcium. The additional effect on 25(OH)D levels of 4000 versus 2000 IU was similar in all subgroups except for body mass index, for which the further increase was smaller in overweight and obese participants compared with normal-weight participants. Supplementation with vitamin D had no significant effects on cardiovascular risk factors or on measures of physical function.

conclusionsAfter accounting for average 70% compliance in long-term trials, doses of 4000 IU vitamin D3 daily may be required to achieve plasma 25(OH)D levels associated with lowest disease risk in observational studies.

Indexed as

AgedAlkaline PhosphataseBone Density Conservation AgentsCalciumCardiovascular DiseasesCholecalciferolDose-Response Relationship, DrugDouble-Blind MethodDrug MonitoringFemaleFollow-Up StudiesHumansMaleOsteoporotic FracturesParathyroid HormonePhysical Fitness25-hydroxyvitamin DAlkaline PhosphataseBone Density Conservation AgentsCalciumCholecalciferolParathyroid HormonePTH protein, humanVitamin DClinical trialMarkers of vitamin D statusOptimum doseVitamin D

Identifiers

PMID27986983
PMCPMC5306173
OpenAlexW2566774299

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.