Evidence map›Paper›PMID 25623291›Full record

Trial reportContemporary clinical trials2015

VITAL-Bone Health: rationale and design of two ancillary studies evaluating the effects of vitamin D and/or omega-3 fatty acid supplements on incident fractures and bone health outcomes in the VITamin D and OmegA-3 TriaL (VITAL).

Meryl S LeBoff, Amy Y Yue, Trisha Copeland, Nancy R Cook, Julie E Buring, JoAnn E Manson

3 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2015. 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 27 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 8 pooled it
6.8field-weighted citation impact, top 3% 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.

NCT01704859 nacompletednot on this mapstarted 2018, after this paper: background citation

VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers

TypeinterventionalSponsorBrigham and Women's HospitalRan2018 to 2022Enrolled25,871ConditionsFracturesArmsVitamin D3 placebo, Fish oil placebo, omega-3 fatty acids (fish oil), Vitamin D3
NCT01747447 nacompletednot on this map

VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture

TypeinterventionalSponsorBrigham and Women's HospitalRan2012 to 2023Enrolled771ConditionsBone Density, Body Composition, Bone HealthArmsVitamin D3 placebo, Fish oil placebo, omega-3 fatty acids (fish oil), Vitamin D3
NCT04573946 naactive not recruitingnot on this mapstarted 2019, after this paper: background citation

VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone

TypeinterventionalSponsorBrigham and Women's HospitalRan2019 to 2026Enrolled25,871ConditionsBone Density, Bone Health, FracturesArmsVitamin D3 placebo, Fish oil placebo, Omega-3 fatty acids (fish oil), Vitamin D3
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 8 syntheses or guidelines pooled it, 50 citations in OpenAlex.

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  7. Calcium plus vitamin D supplementation and risk of fractures: an updated meta-analysis from the National Osteoporosis Foundation.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016
    Pooled it
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  11. Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL).Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2020
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  18. 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
  19. The Effects of Vitamin D Supplementation on Musculoskeletal Health: The VITAL and DO-Health Trials.The journals of gerontology. Series A, Biological sciences and medical sciences · 2023
    Review
  20. 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

6 authors at 1 institution in 1 country.

Meryl S LeBoffDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, United States; Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, United States. Electronic address: MLEBOFF@PARTNERS.ORG.
Amy Y YueDivision of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, United States. Electronic address: AYUE@PARTNERS.ORG.
Trisha CopelandDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02215, United States. Electronic address: PCOPELAND2@PARTNERS.ORG.
Nancy R CookDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02215, United States; Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States. Electronic address: NCOOK@PARTNERS.ORG.
Julie E BuringDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02215, United States; Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States. Electronic address: JBURING@PARTNERS.ORG.
JoAnn E MansonDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02215, United States; Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States. Electronic address: JMANSON@PARTNERS.ORG.
Brigham and Women's Hospital · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
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
VITamin D and OmegA-3 TriaL (VITAL): Interrelationship of Vitamin D and Vitamin K on BoneR01AR059775 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI LEBOFF, MERYL SUSAN · 2012 to 2022
$3.9M
VITamin D OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic MarkersR01AR070854 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI LEBOFF, MERYL SUSAN · 2018 to 2022
$2.8M
Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on FracturesR01AR060574 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI LEBOFF, MERYL SUSAN · 2010 to 2013
$779k
NCATS NIH HHS UL1 TR001102NCI NIH HHS R01 CA138962NCI NIH HHS U01 CA138962NCI NIH HHS U01CA138962NIAMS NIH HHS R01 AR059775NIAMS NIH HHS R01 AR060574NIAMS NIH HHS R01AR060574NIAMS NIH HHS R01 AR070854NIAMS NIH HHS R01AR59775
6 · The paper itself

Abstract

rationaleAlthough vitamin D is widely used to promote skeletal health, definitive data on benefits and risks of supplemental vitamin D alone on bone are lacking. Results from large, randomized controlled trials in the general population are sparse. Data on the effects of supplemental omega-3 fatty acids (FAs) on bone are also limited.

designThe VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled trial assessing the role of vitamin D3 (2000 IU/d) and omega-3 FA (1g/d) supplements in reducing risks of cancer and cardiovascular disease among U.S. men aged ≥50 and women aged ≥55. To comprehensively test effects of supplemental vitamin D and/or omega-3 FAs on skeletal health, the VITAL: Effects on Fractures ancillary study is determining the effects of these supplements on incident fractures among 25,875 participants enrolled in the parent trial. Study investigators adjudicate fractures through a detailed review of medical records and radiological images (hip and femur). In a complementary ancillary, VITAL: Effects on Structure and Architecture is determining the effects of supplemental vitamin D and/or omega-3 FAs on bone with detailed phenotyping during in-person visits. Comprehensive assessments of bone density, turnover, structure/architecture, body composition, and physical performance are being performed at baseline and 2 years post-randomization.

conclusionResults from these studies will clarify the relationship between supplemental vitamin D and/or omega-3 FAs on bone health outcomes, and inform clinical care and public health guidelines on the use of supplemental vitamin D for the primary prevention of fractures in women and men.

Indexed as

Bone DensityAbsorptiometry, PhotonAgedBone Density Conservation AgentsCholecalciferolDietary SupplementsDouble-Blind MethodFatty Acids, Omega-3FemaleFemurFractures, BoneHip JointHumansMaleMiddle AgedTomography, X-Ray ComputedBone Density Conservation AgentsCholecalciferolFatty Acids, Omega-3Bone mineral densityBone turnoverFracturesOmega-3 fatty acidsTrabecular bone scoreVitamin D

Identifiers

PMID25623291
PMCPMC4380672
OpenAlexW1963753917

What OpenQuestion holds

Textmetadata
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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.