Evidence map›Paper›PMID 27926633›Full record

Trial reportObstetrics and gynecology2017

Effects of Calcium, Vitamin D, and Hormone Therapy on Cardiovascular Disease Risk Factors in the Women's Health Initiative: A Randomized Controlled Trial.

Peter F Schnatz, Xuezhi Jiang, Aaron K Aragaki, Matthew Nudy, David M O'Sullivan, Mark Williams, Erin S LeBlanc, Lisa W Martin, JoAnn E Manson, James M Shikany and 6 more

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

Trial report in Obstetrics and gynecology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00000611 (Women's Health Initiative), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT00000611 phase3completednot on this map

Women's Health Initiative (WHI)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)ConditionsBone Diseases, Breast Neoplasms, Cardiovascular Diseases, Colonic NeoplasmsArmshormone replacement therapy, estrogens, progestins, estrogen replacement therapy, diet, fat-restricted
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Observational
  12. 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

16 authors at 2 institutions in 1 country.

Peter F SchnatzDepartments of Obstetrics and Gynecology and Internal Medicine, Reading Hospital, and the Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania; the Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington; Kaiser Permanente, Center for Health Research NW, Portland, Oregon; Department of Internal Medicine, Division of Cardiology, George Washington University School of Medicine and Health Sciences, Washington, DC; the Divisions of Preventive Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts, University of Alabama at Birmingham, School of Medicine, Birmingham, Alabama, and University of Tennessee Health Science Center, Memphis, Tennessee; the Department of Medicine, Stanford University School of Medicine, Stanford University, Stanford Prevention Research Center, Stanford, California; the Office of Research Development, Duke University School of Medicine, Durham, North Carolina; the University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania; the Department of Epidemiology, MedStar Health Research Institute and Georgetown/Howard Universities Center for Clinical and Translational Science, Washington, DC; and UC Davis Medical Center, Sacramento, California.
Xuezhi Jiang
Aaron K Aragaki
Matthew Nudy
David M O'Sullivan
Mark Williams
Erin S LeBlanc
Lisa W Martin
JoAnn E Manson
James M Shikany
Karen C Johnson
Marcia L Stefanick
Martha E Payne
Jane A Cauley
Barbara V Howard
John Robbins
Twitter (United States) · USFred Hutch Cancer Center · US

Funding

Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
University of Alabama at Birmingham's Diabetes Research CenterP30DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Stuart J Frank · 2013 to 2026
$19.5M
Interdisciplinary Research Careers in Women's HealthK12HD043446 · NICHD · DUKE UNIVERSITY · PI AMUNDSEN, CINDY · 2002 to 2023
$9.6M
Biochemical Heterogeneity in Morbidly Obese Women in the WHI Observational StudyR01HL083326 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MACKEY, RACHEL HART · 2006 to 2008
$870k
NCATS NIH HHS UL1 TR001409NHLBI NIH HHS HHSN268201100001INHLBI NIH HHS HHSN268201100002INHLBI NIH HHS HHSN268201100003INHLBI NIH HHS HHSN268201100004INHLBI NIH HHS HHSN268201100046CNHLBI NIH HHS R01 HL083326NIA NIH HHS HHSN271201100004CNICHD NIH HHS K12 HD043446NIDDK NIH HHS P30 DK079626WHI NIH HHS HHSN268201100001CWHI NIH HHS HHSN268201100002CWHI NIH HHS HHSN268201100003CWHI NIH HHS HHSN268201100004C
6 · The paper itself

Abstract

objectiveTo analyze the treatment effect of calcium+vitamin D supplementation, hormone therapy, both, and neither on cardiovascular disease risk factors.

methodsWe conducted a prospective, randomized, double-blind, placebo-controlled trial among Women's Health Initiative (WHI) participants. The predefined primary outcome was low-density lipoprotein cholesterol (LDL-C).

resultsBetween September 1993 and October 1998, a total of 68,132 women aged 50-79 years were recruited and randomized to the WHI-Dietary Modification (n=48,835) and WHI-Hormone Therapy trials (n=27,347). Subsequently, 36,282 women from WHI-Hormone Therapy (16,089) and WHI-Dietary Modification (n=25,210) trials were randomized in the WHI-Calcium+Vitamin D trial to 1,000 mg elemental calcium carbonate plus 400 international units vitamin D3 daily or placebo. Our study group included 1,521 women who participated in both the hormone therapy and calcium+vitamin D trials and were in the 6% subsample of trial participants with blood sample collections at baseline and years 1, 3, and 6. The average treatment effect with 95% confidence interval, for LDL-C, compared with placebo, was -1.6, (95% confidence interval [CI] -5.5 to 2.2) mg/dL for calcium+vitamin D alone, -9.0 (95% CI -13.0 to -5.1) mg/dL for hormone therapy alone, and -13.8 (95% CI -17.8 to -9.8) mg/dL for the combination. There was no evidence of a synergistic effect of calcium+vitamin D+hormone therapy on LDL-C (P value for interaction=.26) except in those with low total intakes of vitamin D, for whom there was a significant synergistic effect on LDL (P value for interaction=.03).

conclusionReductions in LDL-C were greater among women randomized to both calcium+vitamin D and hormone therapy than for those randomized to either intervention alone or to placebo. The treatment effect observed in the calcium+vitamin D+hormone therapy combination group may be additive rather than synergistic. For clinicians and patients deciding to begin calcium+vitamin D supplementation, current use of hormone therapy should not influence that decision. CLINICAL

trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT00000611.

Indexed as

Estrogen Replacement TherapyAgedCalcium CarbonateCalcium, DietaryCardiovascular DiseasesCholecalciferolCholesterol, LDLDietary SupplementsDouble-Blind MethodDrug SynergismDrug Therapy, CombinationEstrogens, Conjugated (USP)FemaleHumansMedroxyprogesterone AcetateMiddle AgedCalcium CarbonateCalcium, DietaryCholecalciferolCholesterol, LDLEstrogens, Conjugated (USP)Medroxyprogesterone AcetateVitamins

Identifiers

PMID27926633
PMCPMC5177479
OpenAlexW2559978364

What OpenQuestion holds

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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.