Evidence map›Paper›PMID 26196201›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2016

Pilot Study Evaluating Efficacy of 2 Regimens for Hypovitaminosis D Repletion in Pediatric Inflammatory Bowel Disease.

Robert Z Simek, Jarod Prince, Sana Syed, Cary G Sauer, Bernadette Martineau, Tanya Hofmekler, Alvin J Freeman, Archana Kumar, Barbara O McElhanon, Bess T Schoen and 5 more

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 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.

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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Vitamin D for the treatment of inflammatory bowel disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. [Mechanism of action and exogenous supplementation of vitamin D in Crohn's disease].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2023
    Article
  7. Review
  8. Article
  9. Review
  10. 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

15 authors at 3 institutions in 1 country.

Robert Z Simek*Department of Pediatrics, Emory University School of Medicine †Department of Medicine, Emory University School of Medicine and the Atlanta VA Medical Center ‡Children's Healthcare of Atlanta, Atlanta, GA.
Jarod Prince
Sana Syed
Cary G Sauer
Bernadette Martineau
Tanya Hofmekler
Alvin J Freeman
Archana Kumar
Barbara O McElhanon
Bess T Schoen
Gayathri Tenjarla
Courtney McCracken
Thomas R Ziegler
Vin Tangpricha
Subra Kugathasan
Children's Healthcare of Atlanta · USEmory University · USAtlanta VA Medical Center · US

Funding

Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Gene discoveries in subjects with Crohn's disease of African descentR01DK087694 · NIDDK · EMORY UNIVERSITY · PI KUGATHASAN, SUBRA · 2011 to 2023
$10.3M
Patient Oriented Research In Clinical NutritionK24DK096574 · NIDDK · EMORY UNIVERSITY · PI ZIEGLER, THOMAS R · 2012 to 2016
$888k
Role of T-cells in Osteoporosis in Women Undergoing Surgical MenopauseK23AR054334 · NIAMS · EMORY UNIVERSITY · PI TANGPRICHA, VIN · 2007 to 2011
$641k
NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1TR000454NIAMS NIH HHS K23 AR054334NIDDK NIH HHS DK087694NIDDK NIH HHS K24 DK096574NIDDK NIH HHS R01 DK087694
6 · The paper itself

Abstract

objectivesVitamin D is critical for skeletal health; hypovitaminosis D is common in pediatric inflammatory bowel disease (IBD), yet optimal repletion therapy is not well studied. We aimed to conduct a pilot trial comparing the efficacy of 2 vitamin D regimens of weekly dosing for the repletion of hypovitaminosis D in pediatric IBD.

methodsSubjects identified from our IBD clinic with 25-hydroxyvitamin D (25[OH]D) concentrations <30 ng/mL were randomized to 10,000 (n = 18) or 5000 (n = 14) IU of oral vitamin D3/10 kg body weight per week for 6 weeks. Serum 25(OH)D, Ca, and parathyroid hormone concentrations were measured at baseline, week 8, and week 12.

resultsIn the higher dosing group, serum 25(OH)D increased from 23.7 ± 8.5 ng/mL at baseline to 49.2 ± 13.6 ng/mL at 8 weeks; P < 0.001. In the lower dosing group, serum 25(OH)D increased from 24.0 ± 7.0 ng/mL at baseline to 41.5 ± 9.6 ng/mL at 8 weeks; P < 0.001. At 12 weeks, serum 25(OH)D concentrations were 35.1 ± 8.4 and 30.8 ± 4.2 ng/mL for the higher and lower dose regimens, respectively. Mean serum Ca and parathyroid hormone concentrations did not significantly change during the study. No patient exhibited hypercalcemia, and no serious adverse events occurred.

conclusionsBoth treatment arms were safe and effective at normalizing vitamin D nutriture in pediatric IBD. Although significant repletion of 25(OH)D concentration was achieved in both dosing groups at 8 weeks, this effect was lost by the 12-week follow-up. Maintenance vitamin D therapy following initial repletion is likely required to maintain long-term normalized vitamin D status.

Indexed as

AdolescentCalciumChildCholecalciferolFemaleHumansInflammatory Bowel DiseasesMaleParathyroid HormonePediatricsPilot ProjectsTreatment OutcomeVitamin DVitamin D DeficiencyVitamins25-hydroxyvitamin DCalciumCholecalciferolParathyroid HormoneVitamin DVitamins

Identifiers

PMID26196201
PMCPMC4863642
OpenAlexW2396867195

What OpenQuestion holds

Textmetadata
LicenceTDM
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.