Evidence map›Paper›PMID 24926949›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2014

Maintenance of optimal vitamin D status in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing two regimens.

Helen M Pappa, Paul D Mitchell, Hongyu Jiang, Sivan Kassiff, Rajna Filip-Dhima, Diane DiFabio, Nicolle Quinn, Rachel C Lawton, M E S Bronzwaer, Mirjam Koenen and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Vitamin D for the treatment of inflammatory bowel disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Trial
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  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. [Inflammatory Bowel Disease and Vitamin D].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2020
    Review
  13. Levels of Vitamin D Are Low After Crohn's Disease Is Established But Not Before.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
    Article
  14. Review
  15. Review
  16. Review
  17. Article
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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

11 authors.

Helen M PappaCenter for Inflammatory Bowel Diseases (H.M.P., S.K.), Clinical Research Center Design and Analysis Core (P.D.M., H.J., R.F.-D.), and Clinical and Translational Study Unit (D.D., N.Q.), Children's Hospital Boston, Boston, Massachusetts 02115; Center for Psychosocial Research in GI, Northwestern University Feinberg School of Medicine (R.C.L.), Chicago, Illinois 60611; Academic Medical Center (M.E.S.B., M.K.), 1105 AZ Amsterdam, The Netherlands; and Divisions of Adolescent Medicine and Endocrinology, Hasbro Children's Hospital and Alpert Medical School of Brown University (C.M.G.), Providence, Rhode Island 02903.
Paul D Mitchell
Hongyu Jiang
Sivan Kassiff
Rajna Filip-Dhima
Diane DiFabio
Nicolle Quinn
Rachel C Lawton
M E S Bronzwaer
Mirjam Koenen
Catherine M Gordon

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
STRUCTURE-FUNCTION RELATIONSHIPS IN THE ALIMENTARY TRACTP30DK034854 · NIDDK · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI WAYNE I LENCER · 1986 to 2026
$32.4M
WIRELESS CAPSULE ENDOSCOPY TO EVALUATE THE SMALL INTESTINE M01RR002172 · NCRR · CHILDREN'S HOSPITAL BOSTON · PI GRAND, RICHARD J · 1985 to 2008
$16.0M
Optimization of vitamin D status and its effects on bone health of youth with IBDK23DK076979 · NIDDK · BOSTON CHILDREN'S HOSPITAL · PI PAPPA, HELEN M · 2008 to 2012
$902k
NCRR NIH HHS M01 RR002172NCRR NIH HHS MO1-RR02172NCRR NIH HHS UL1 RR025758NCRR NIH HHS UL1RR025758NIDDK NIH HHS K23 DK076979NIDDK NIH HHS P30 DK034854
6 · The paper itself

Abstract

contextVitamin D promotes bone health and regulates the immune system, both important actions for pediatric patients with inflammatory bowel disease (IBD). The supplementation dose that would maintain optimal serum 25-hydroxyvitamin D concentration (25OHD ≥ 32 ng/mL) is unknown.

objectiveThe objective of the study was to compare two supplementation regimens' efficacy and safety in maintaining optimal 25OHD in children with IBD.

designThis was a randomized, not blinded, controlled trial.

settingThe trial was conducted in the Boston Children's Hospital Clinical and Translational Study Unit.

participantsSixty-three patients, aged 8-18 years with IBD and baseline 25OHD greater than 20 ng/mL were enrolled; 48 completed the study, and one withdrew for adverse events.

interventionArm A received 400 IU of oral vitamin D2 daily (n = 32). Arm B received 1000 IU daily in the summer/fall and 2000 IU in the winter/spring (n = 31). MAIN OUTCOME: The main outcome was the probability of maintaining 25OHD of 32 ng/mL or greater in all trimonthly visits for 12 months.

resultsThree participants in arm A (9.4%) and three in arm B (9.7%) achieved the primary outcome (P = .97). The incidence of adverse events, all minor, did not differ. More participants in arm A developed C-reactive protein level of 1 mg/dL or greater (31% vs 10%, P = .04) and IL-6 greater than 3 pg/mL (54% vs 27%, P = .05).

conclusionsDaily oral vitamin D2 doses up to 2000 IU were inadequate to maintain optimal 25OHD but were well tolerated. The finding of lower incidence of elevated inflammatory markers and cytokines among participants receiving higher vitamin D2 doses merits further study.

Indexed as

Administration, OralAdolescentChildChild, PreschoolColitis, UlcerativeCrohn DiseaseDietary SupplementsErgocalciferolsFemaleHumansMaleSurveys and QuestionnairesTreatment OutcomeUltraviolet RaysVitamin DVitamin D Deficiency25-hydroxyvitamin DErgocalciferolsVitamin DVitamins

Identifiers

PMID24926949
PMCPMC4154083

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.