Evidence map›Paper›PMID 29112461›Full record

Trial reportJournal of child and adolescent psychopharmacology2018

Calcium and Vitamin D Supplementation in Boys with Risperidone-Induced Hyperprolactinemia: A Randomized, Placebo-Controlled Pilot Study.

Chadi A Calarge, James A Mills, Ekhard E Ziegler, Janet A Schlechte

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

Trial report in Journal of child and adolescent psychopharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00799383 (Counteracting Risperidone-Induced Hyperprolactinemia in Youths), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 26% 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.

NCT00799383 phase3completednot on this map

Counteracting Risperidone-Induced Hyperprolactinemia in Youths

TypeinterventionalSponsorChadi A. CalargeRan2008 to 2014Enrolled47ConditionsRisperidone-induced HyperprolactinemiaArmsCalcium and Vitamin D, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Observational
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

4 authors at 2 institutions in 1 country.

Chadi A Calarge1 Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine , Houston, Texas.
James A Mills3 Department of Psychiatry, The University of Iowa , Iowa City, Iowa.
Ekhard E Ziegler4 Department of Pediatrics, The University of Iowa , Iowa City, Iowa.
Janet A Schlechte5 Department of Internal Medicine, The University of Iowa , Iowa City, Iowa.
University of Iowa · USBaylor College of Medicine · US

Funding

Counteracting Risperidone-Induced Hyperprolactinemia in YouthsK23MH085005 · NIMH · UNIVERSITY OF IOWA · PI CALARGE, CHADI A. · 2009 to 2013
$866k
NIMH NIH HHS K23 MH085005
6 · The paper itself

Abstract

backgroundThe chronic use of antipsychotics has been associated with impaired bone mineralization, partially mediated by hyperprolactinemia. We examined if calcium and vitamin D supplementation promote bone mineral accrual in boys with risperidone-induced hyperprolactinemia.

methodsBetween February 2009 and November 2013, medically healthy, 5- to 17-year-old boys were enrolled in a 36-week double-blind, placebo-controlled study, examining the skeletal effects of supplementation with 1250 mg calcium carbonate and 400 IU of vitamin D3 in risperidone-induced hyperprolactinemia. Anthropometric, dietary, physical activity, and psychiatric assessments were conducted at baseline and week 18 and 36. Plasma prolactin and vitamin D concentrations were measured at baseline and week 36. Total body less head bone mineral content (BMC) and radius trabecular bone mineral density (BMD) were measured at baseline, week 18, and week 36, using dual-energy X-ray absorptiometry and peripheral quantitative computed tomography, respectively. Linear mixed-effects regression analysis examined the longitudinal effect of treatment on skeletal outcomes.

resultsForty-seven boys (mean age: 11.0 ± 2.6 years) were randomized and 38 completed the study. At study entry, the average dietary calcium intake was below the recommended limit, but the average vitamin D concentration was normal. Calcium and vitamin D supplementation failed to significantly increase BMC or trabecular BMD. It also failed to affect several other skeletal and anthropometric outcomes, including plasma vitamin D concentration.

conclusionsIn this 9-month long pilot study, supplementation with a modest dose of calcium and vitamin D did not increase bone mass accrual in risperidone-treated boys with hyperprolactinemia. Alternative approaches should be investigated to optimize bone health in this population to prevent future morbidity and premature mortality. ClinicalTrials.gov Identifier: NCT00799383.

Indexed as

Absorptiometry, PhotonAdolescentAntipsychotic AgentsBone DensityCalcium CarbonateCalcium, DietaryChildChild, PreschoolCholecalciferolDietary SupplementsDouble-Blind MethodHumansHyperprolactinemiaMalePilot ProjectsRegression AnalysisAntipsychotic AgentsCalcium CarbonateCalcium, DietaryCholecalciferolRisperidonebone masscalciumchildrenhyperprolactinemiarisperidonevitamin D

Identifiers

PMID29112461
PMCPMC5831755
OpenAlexW2767950874

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.