Evidence map›Paper›PMID 24290111›Full record

Trial reportMayo Clinic proceedings2013

Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial.

Sara S Oberhelman, Michael E Meekins, Philip R Fischer, Bernard R Lee, Ravinder J Singh, Stephen S Cha, Brian M Gardner, John M Pettifor, Ivana T Croghan, Tom D Thacher

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

Trial report in Mayo Clinic proceedings, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01240265 (Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum), which is not on this map. Cited by 45 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 7 pooled it
5.9field-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.

NCT01240265 phase2 / phase3completednot on this map

Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum

TypeinterventionalSponsorMayo ClinicRan2010 to 2011Enrolled80ConditionsVitamin D Deficiency, Rickets, Infant Nutrition DisordersArmsVitamin D3
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 7 syntheses or guidelines pooled it, 115 citations in OpenAlex.

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  19. Analysis of vitamin DJournal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Sara S OberhelmanDepartment of Family Medicine, Mayo Clinic, Rochester, MN. Electronic address: Oberhelman.sara@mayo.edu.
Michael E Meekins
Philip R Fischer
Bernard R Lee
Ravinder J Singh
Stephen S Cha
Brian M Gardner
John M Pettifor
Ivana T Croghan
Tom D Thacher
Mayo Clinic in Arizona · USMayo Clinic · USMayo Clinic in Florida · USUniversity of the Witwatersrand · ZA

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
NCATS NIH HHS UL1 TR000135
6 · The paper itself

Abstract

objectiveTo determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants. PATIENTS AND

methodsForty mothers with exclusively breast-fed infants were randomized to receive oral cholecalciferol (vitamin D3) 5000 IU/d for 28 days or 150,000 IU once. Maternal serum, breast milk, and urine were collected on days 0, 1, 3, 7, 14, and 28; infant serum was obtained on days 0 and 28. Enrollment occurred between January 7, 2011, and July 29, 2011.

resultsIn mothers given daily cholecalciferol, concentrations of serum and breast milk cholecalciferol attained steady levels of 18 and 8 ng/mL, respectively, from day 3 through 28. In mothers given the single dose, serum and breast milk cholecalciferol peaked at 160 and 40 ng/mL, respectively, at day 1 before rapidly declining. Maternal milk and serum cholecalciferol concentrations were related (r=0.87). Infant mean serum 25-hydroxyvitamin D concentration increased from 17±13 to 39±6 ng/mL in the single-dose group and from 16±12 to 39±12 ng/mL in the daily-dose group (P=.88). All infants achieved serum 25-hydroxyvitamin D concentrations of more than 20 ng/mL.

conclusionEither single-dose or daily-dose cholecalciferol supplementation of mothers provided breast milk concentrations that result in vitamin D sufficiency in breast-fed infants. CLINICAL

trial registrationclinicaltrials.gov NCT01240265.

Indexed as

Breast FeedingDietary SupplementsMothersAdultCholecalciferolDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansInfantInfant, NewbornLactationMaleMilk, HumanTime FactorsTreatment OutcomeCholecalciferolVitamins1,25-dihydroxyvitamin D1,25(OH)(2)D25-hydroxyvitamin D25(OH)DAAPAmerican Academy of PediatricsInstitute of MedicineIOM

Identifiers

PMID24290111
PMCPMC3923377
OpenAlexW2030794969

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.