Evidence map›Paper›PMID 31669447›Full record

Trial reportContemporary clinical trials2019

Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment.

Heike Luttmann-Gibson, Samia Mora, Carlos A Camargo, Nancy R Cook, Olga V Demler, Amit Ghoshal, Jay Wohlgemuth, Kris Kulkarni, Julia Larsen, James Prentice and 7 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01169259 (Vitamin D and Omega-3 Trial), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT01169259 phase3active not recruitingnot on this map

Vitamin D and Omega-3 Trial (VITAL)

TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2026Enrolled25,871ConditionsCancer, Cardiovascular DiseaseArmsvitamin D3, omega-3 fatty acids (fish oil), Vitamin D3 placebo, Fish oil placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

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  3. Effect of Daily Vitamin D Supplementation on Risk of Upper Respiratory Infection in Older Adults: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
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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

17 authors at 3 institutions in 1 country.

Heike Luttmann-GibsonDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Landmark Center West, 401 Park Drive, Boston, MA 02215, USA.
Samia MoraDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Division of Cardiovascular Medicine and Center for Lipid Metabolomics, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: smora@bwh.harvard.edu.
Carlos A CamargoDepartment of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.
Nancy R CookDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.
Olga V DemlerDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.
Amit GhoshalQuest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.
Jay WohlgemuthQuest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.
Kris KulkarniAtherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA; VAP Diagnostics R&D Laboratory, 201 London Pkwy, Birmingham, AL 3521, USA.
Julia LarsenQuest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.
James PrenticeQuest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.
Michael CobbleAtherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA.
Vadim BubesDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.
Chunying LiDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.
Georgina FriedenbergDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.
I-Min LeeDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.
Julie E BuringDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.
JoAnn E MansonDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.
Harvard University · USQuest Diagnostics (United States) · USBrigham and Women's Hospital · US

Funding

VITamin D and omegA-3 triaL (VITAL)U01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2009 to 2014
$23.6M
The VITamin D and OmegA-3 TriaL (VITAL)R01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2015 to 2019
$20.9M
Reducing Inflammation for the Prevention of CVD: A Focus on Eicosanoid PathwaysR01HL134811 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MORA, SAMIA · 2017 to 2020
$3.0M
Circulating plasma metabolites, diet, and risk of type 2 diabetesR01DK112940 · NIDDK · BRIGHAM AND WOMEN'S HOSPITAL · PI HU, FRANK B, MORA, SAMIA · 2018 to 2021
$2.9M
Patient Centered Approaches to Preventing ASCVD EventsK24HL136852 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SAMIA MORA · 2018 to 2026
$1.1M
CHD Risk and Metabolomic Profiles of Discordant LipidsK01HL135342 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI DEMLER, OLGA · 2017 to 2021
$857k
NCI NIH HHS R01 CA138962NCI NIH HHS U01 CA138962NHLBI NIH HHS K01 HL135342NHLBI NIH HHS K24 HL136852NHLBI NIH HHS R01 HL134811NIDDK NIH HHS R01 DK112940
6 · The paper itself

Abstract

backgroundThe VITamin D and OmegA-3 TriaL (VITAL) is a completed randomized, placebo-controlled trial of vitamin D

methodsBaseline 25(OH)D was measured in 15,804 participants (mean age 68 years.; 50.8% women; 15.7% African Americans) and in 1660 1-year follow-up samples using liquid chromatography-tandem mass spectrometry and chemiluminescence. Calcium and parathyroid hormone (iPTH) were measured by chemiluminescence and spectrophotometry respectively.

resultsMean baseline total 25(OH)D (ng/mL ± SD) was 30.8 ± 10.0 ng/mL, and correlated inversely with iPTH (r = -0.28), p < .001. After adjusting for clinical factors, 25(OH)D (ng/mL ± SE) was lower in men vs women (29.7 ± 0.30 vs 31.4 ± 0.30, p < .0001) and in African Americans vs whites (27.9 ± 0.29 vs 32.5 ± 0.22, p < .0001). It was also lower with increasing BMI, smoking, and latitude, and varied by season. Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo. The largest increases were noted among individuals with low baseline and African Americans. Results were similar for chemiluminescent immunoassay. Mean calcium was unchanged, and iPTH decreased with treatment.

conclusionIn VITAL, baseline 25(OH)D varied by clinical subgroups, was lower in men and African Americans. Concentrations increased with vitamin D supplementation, with the greatest increases in those with lower baseline 25(OH)D. The seasonal trends in 25(OH)D, iPTH, and calcium may be relevant when interpreting 25(OH)D levels for clinical treatment decisions. CLINICAL

trial registrationVITAL ClinicalTrials.gov number NCT01169259.

Indexed as

CholecalciferolDietary SupplementsFatty Acids, Omega-3Vitamin DAge FactorsBiomarkersBlack or African AmericanBody Mass IndexCalciumCardiovascular DiseasesComorbidityDouble-Blind MethodFemaleHumansMaleMiddle Aged25-hydroxyvitamin DBiomarkersCalciumCholecalciferolFatty Acids, Omega-3Vitamin D25-hydroxyvitamin DParathyroid hormoneSeasonal effectsVITAL trialVitamin D

Identifiers

PMID31669447
PMCPMC6875603
OpenAlexW2981973650

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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.