Evidence map›Paper›PMID 23587190›Full record

Trial reportNutrition journal2013

Randomized placebo-controlled trial of high-dose prenatal third-trimester vitamin D3 supplementation in Bangladesh: the AViDD trial.

Daniel E Roth, Abdullah Al Mahmud, Rubhana Raqib, Evana Akhtar, Nandita Perumal, Brendon Pezzack, Abdullah H Baqui

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

Trial report in Nutrition journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01126528 (The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function), which is not on this map. Cited by 53 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 14 pooled it
8.5field-weighted citation impact, top 2% 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.

NCT01126528 phase2completednot on this map

The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2010 to 2012Enrolled160ConditionsPregnancyArmsVitamin D3, Placebo control
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 14 syntheses or guidelines pooled it, 118 citations in OpenAlex.

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  6. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2024
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  9. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2019
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  13. Vitamin D supplementation during pregnancy: Updated meta-analysis on maternal outcomes.The Journal of steroid biochemistry and molecular biology · 2016
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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

7 authors at 2 institutions in 3 countries.

Daniel E Roth
Abdullah Al Mahmud
Rubhana Raqib
Evana Akhtar
Nandita Perumal
Brendon Pezzack
Abdullah H Baqui
International Centre for Diarrhoeal Disease Research · BDSickKids Foundation · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntenatal vitamin D status may be associated with the risk of adverse pregnancy and neonatal outcomes; however, the benefits of vitamin D supplementation during pregnancy remain unknown.

methodsWe conducted a double-blind placebo-controlled randomized trial to evaluate the effect of high-dose prenatal 3rd trimester vitamin D3 supplementation on maternal and neonatal (cord blood) serum 25-hydroxyvitamin D (25(OH)D) concentration (primary biochemical efficacy outcome) and maternal serum calcium concentration (primary safety measure). Eligibility criteria were pregnant women aged 18 to <35 years, at 26 to 29 weeks gestation, and residing in Dhaka, Bangladesh. 160 women were randomized by 1:1 allocation to one of two parallel intervention groups; placebo (n = 80) or 35,000 IU/week of vitamin D3 (n = 80) until delivery. All participants, study personnel and study investigators were blind to treatment allocation.

resultsMean maternal 25(OH)D concentration was similar in the vitamin D and placebo groups at baseline (45 vs. 44 nmol/L; p = 0.66), but was significantly higher in the vitamin D group vs. placebo group among mothers at delivery (134 vs. 38 nmol/L; p < 0.001) and newborns (cord blood: 103 vs. 39; p < 0.001). In the vitamin D group, 95% of neonates and 100% of mothers attained 25(OH)D >50 nmol/L, versus 21% mothers and 19% of neonates in the placebo group. No participants met criteria for hypercalcemia, there were no known supplement-related adverse events, and major pregnancy outcomes were similar between groups.

conclusionsAntenatal 3rd-trimester vitamin D3 supplementation (35,000 IU/week) significantly raised maternal and cord serum 25(OH)D concentrations above 50 nmol/L in almost all participants without inducing hypercalcemia or other observed safety concerns. Doses up to 35,000 IU/week may be cautiously used in further research aimed at establishing the clinical effects and safety of vitamin D3 supplementation in pregnancy.

trial registrationThis trial was registered at ClinicalTrials.gov (NCT01126528).

Indexed as

Dietary SupplementsPregnancy Trimester, ThirdAdolescentAdultBangladeshCalciumCholecalciferolCreatinineCross-Sectional StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleFetal BloodHumansInfant, NewbornLinear Models25-hydroxyvitamin DCalciumCholecalciferolCreatinineParathyroid HormoneSerum AlbuminVitamin D

Identifiers

PMID23587190
PMCPMC3641012
OpenAlexW2014131087

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.