Evidence map›Paper›PMID 19101755›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 USA2009

High-dose oral vitamin D3 supplementation in the elderly.

C J Bacon, G D Gamble, A M Horne, M A Scott, I R Reid

3 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed 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, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 71 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 8 pooled it
7.3field-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.

NCT02138591 phase3withdrawnnot on this mapstarted 2016, after this paper: background citation

Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Major Surgical Procedures.

TypeinterventionalSponsorUniversity of Missouri, Kansas CityRan2016 to 2016Enrolled0ConditionsVitamin d DeficiencyArmsBlood draw pre-operatively, Blood draw post-operative Day 1, Blood draw post-operative Day 2
NCT02868827 phase2 / phase3terminatednot on this mapstarted 2017, after this paper: background citation

Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency in Intensive Care Unit- A Randomized Controlled Trial.

TypeinterventionalSponsorKing Abdullah Medical CityRan2017 to 2019Enrolled127ConditionsVitamin D Deficiency, Critical IllnessArmsCholecalciferol, Milk (Nestle)
NCT03747523 early_phase1completednot on this mapstarted 2019, after this paper: background citation

Study of the Effect of Ergocalciferol on Plasma and Urinary Mucin-1 Levels in Healthy Individuals and Individuals With Autosomal Dominant Tubulo-Interstitial Kidney Disease Due to MUC1 Mutations (ADTKD-MUC1)

TypeinterventionalSponsorWake Forest University Health SciencesRan2019 to 2020Enrolled44ConditionsErgocalciferolArmsErgocalciferol
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 8 syntheses or guidelines pooled it, 166 citations in OpenAlex.

  1. Pooled it
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  3. Vitamin D supplementation and its influence on muscle strength and mobility in community-dwelling older persons: a systematic review and meta-analysis.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2017
    Pooled it
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  6. Large, single-dose, oral vitamin D supplementation in adult populations: a systematic review.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2014
    Pooled it
  7. Vitamin D supplementation for prevention of mortality in adults.The Cochrane database of systematic reviews · 2014
    Pooled it
  8. Relationship between vitamin D, parathyroid hormone, and bone health.The Journal of clinical endocrinology and metabolism · 2011
    Pooled it
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  18. Can one or two high doses of oral vitamin D3 correct insufficiency in a non-supplemented rheumatologic population?Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2013
    Trial
  19. The effect of prior bisphosphonate therapy on the subsequent therapeutic effects of strontium ranelate over 2 years.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2012
    Trial
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11 more citing papers are in PubMed but not listed here.

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 1 country.

C J BaconDepartment of Medicine, University of Auckland, Auckland, New Zealand.
G D Gamble
A M Horne
M A Scott
I R Reid
University of Auckland · NZAuckland District Health Board · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

summaryDaily dosing with vitamin D often fails to achieve optimal outcomes, and it is uncertain what the target level of 25-hydroxyvitamin D should be. This study found that large loading doses of vitamin D(3) rapidly and safely normalize 25OHD levels, and that monthly dosing is similarly effective after 3-5 months. With baseline 25OHD > 50 nmol/L, vitamin D supplementation does not reduce PTH levels.

introductionThere is concern that vitamin D supplementation doses are frequently inadequate, and that compliance with daily medication is likely to be suboptimal.

methodsThis randomized double-blind trial compares responses to three high-dose vitamin D(3) regimens and estimates optimal 25-hydroxyvitamin D (25OHD) levels, from changes in parathyroid hormone (PTH), and procollagen type I amino-terminal propeptide (P1NP) in relation to baseline 25OHD. Sixty-three elderly participants were randomized to three regimens of vitamin D supplementation: a 500,000-IU loading dose; the loading dose plus 50,000 IU/month; or 50,000 IU/month.

resultsThe Loading and Loading + Monthly groups showed increases in 25OHD of 58 +/- 28 nmol/L from baseline to 1 month. Thereafter, levels gradually declined to plateaus of 69 +/- 5 nmol/L and 91 +/- 4 nmol/l, respectively. In the Monthly group, 25OHD reached a plateau of ~80 +/- 20 nmol/L at 3-5 months. There were no changes in serum calcium concentrations. PTH and P1NP were only suppressed by vitamin D treatment in those with baseline 25OHD levels <50 and <30 nmol/L, respectively.

conclusionsLarge loading doses of vitamin D(3) rapidly and safely normalize 25OHD levels in the frail elderly. Monthly dosing is similarly effective and safe, but takes 3-5 months for plateau 25OHD levels to be reached.

Indexed as

Dietary SupplementsAdministration, OralAgedAged, 80 and overCholecalciferolDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFrail ElderlyHand StrengthHumansMaleParathyroid HormonePeptide FragmentsProcollagen25-hydroxyvitamin DCholecalciferolParathyroid HormonePeptide FragmentsProcollagenprocollagen Type I N-terminal peptideVitamin DVitamins

Identifiers

PMID19101755
OpenAlexW2103819742

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.