Evidence map›Paper›PMID 22456619›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2012

Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens.

Helen M Pappa, Paul D Mitchell, Hongyu Jiang, Sivan Kassiff, Rajna Filip-Dhima, Diane DiFabio, Nicolle Quinn, Rachel C Lawton, Mark Varvaris, Stephanie Van Straaten and 1 more

Open access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
6.9field-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.

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

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Pooled it
  2. Vitamin D for the treatment of inflammatory bowel disease.The Cochrane database of systematic reviews · 2023
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  11. Observational
  12. Article
  13. Review
  14. Patterns of vitamin D testing and supplementation for children with inflammatory bowel disease in Australasia.JGH open : an open access journal of gastroenterology and hepatology · 2024
    Article
  15. Review
  16. Review
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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 at 5 institutions in 2 countries.

Helen M PappaDivision of Gastroenterology and Nutrition, Children's Hospital Boston, Boston, Massachusetts 02115, USDA . Helen.pappa@childrens.harvard.edu
Paul D Mitchell
Hongyu Jiang
Sivan Kassiff
Rajna Filip-Dhima
Diane DiFabio
Nicolle Quinn
Rachel C Lawton
Mark Varvaris
Stephanie Van Straaten
Catherine M Gordon
Boston Children's Hospital · USCore Laboratories (United States) · USAcademic Medical Center · NLJohns Hopkins University · USNorthwestern University · US

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
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 UL1 RR 025758NCRR NIH HHS UL1 RR025758NIDDK NIH HHS K23 DK076979
6 · The paper itself

Abstract

contextVitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied.

objectiveThe aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens. DESIGN AND

settingWe conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators. PATIENTS: Eligibility criteria included diagnosis of IBD, age 5-21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events.

interventionPatients received orally for 6 wk: vitamin D(2), 2,000 IU daily (arm A, control); vitamin D(3), 2,000 IU daily (arm B); vitamin D(2), 50,000 IU weekly (arm C); and an age-appropriate calcium supplement.

main outcome measureWe measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate.

resultsAfter 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± SE was -5.6 ± 5.5 (arm A); -0.1 ± 4.2 (arm B); -4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up.

conclusionsOral doses of 2,000 IU vitamin D(3) daily and 50,000 IU vitamin D(2) weekly for 6 wk are superior to 2,000 IU vitamin D(2) daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms.

Indexed as

AdolescentCalciumChildCholecalciferolDose-Response Relationship, DrugErgocalciferolsFemaleFollow-Up StudiesHumansInflammatory Bowel DiseasesMaleParathyroid HormonePatient ComplianceTreatment OutcomeVitamin DVitamin D Deficiency25-hydroxyvitamin DCalciumCholecalciferolErgocalciferolsParathyroid HormoneVitamin DVitamins

Identifiers

PMID22456619
PMCPMC3387426
OpenAlexW2027953492

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.