Evidence map›Paper›PMID 33045402›Full record

ArticleContemporary clinical trials2021

The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design.

Rui Wang, Victor DeGruttola, Quanhong Lei, Kenneth H Mayer, Susan Redline, Aditi Hazra, Samia Mora, Walter C Willett, Davaasambuu Ganmaa, JoAnn E Manson

2 registry-linked trialsOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 36 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 4 pooled it
10.1field-weighted citation impact, top 1% 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.

NCT04536298 phase3completednot on this map

A Cluster-Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Vitamin D3 Supplementation to Reduce Disease Severity in Persons With Newly Diagnosed COVID-19 Infection and to Prevent Infection in Household Members

TypeinterventionalSponsorBrigham and Women's HospitalRan2020 to 2024Enrolled2,024ConditionsCOVID-19Armsvitamin D, Placebo
NCT04777981 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Efficacy of Cannabidiol in Combination With Red Algae (CBDRA60) to Prevent or Reduce Symptoms of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection PASC

TypeinterventionalSponsorAnewsha Therapeutics Inc.Ran2022 to 2022Enrolled60ConditionsCOVID-19, SARArmsCBDRA60 supplement, Placebo
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 4 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  7. Health Effects of Vitamin D Supplementation: Lessons Learned From Randomized Controlled Trials and Mendelian Randomization Studies.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2023
    Review
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  13. Vitamin D, infections and immunity.Reviews in endocrine & metabolic disorders · 2022
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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

10 authors at 6 institutions in 1 country.

Rui WangDepartment of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA; Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA. Electronic address: rwang@hsph.harvard.edu.
Victor DeGruttolaDepartment of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA.
Quanhong LeiTakeda Pharmaceutical Company, MA, USA.
Kenneth H MayerFenway Health, and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Susan RedlineDivision of Sleep Medicine and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Aditi HazraDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Samia MoraDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Walter C WillettDepartment of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Davaasambuu GanmaaDepartment of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
JoAnn E MansonDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Brigham and Women's Hospital · USHarvard University · USCircadian (United States) · USFenway Health · USHarvard Pilgrim Health Care · USTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts.

methodsWe report the rationale and design of a planned pragmatic, cluster randomized, double-blinded trial (N = 2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts), randomized to either vitamin D3 (loading dose, then 3200 IU/day) or placebo in a 1:1 ratio and a household cluster design. The study duration is 4 weeks. The primary outcome for newly diagnosed individuals is the occurrence of hospitalization and/or mortality. Key secondary outcomes include symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts. Changes in vitamin D 25(OH)D levels will be assessed and their relation to study outcomes will be explored.

conclusionsThe proposed pragmatic trial will allow parallel testing of vitamin D3 supplementation for early treatment and post-exposure prophylaxis of COVID-19. The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.

Indexed as

COVID-19 Drug TreatmentDietary SupplementsVitamin DAdultComorbidityCOVID-19Double-Blind MethodHospitalizationHumansMiddle AgedMinority GroupsPragmatic Clinical Trials as TopicRisk FactorsSARS-CoV-2SeroconversionSeverity of Illness IndexVitamin DCluster randomizationCOVID-19Early treatmentProphylaxisSARS-CoV-2Vitamin D

Identifiers

PMID33045402
PMCPMC7547023
OpenAlexW3092315742

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.