Evidence map›Paper›PMID 20216560›Full record

Trial reportEuropean journal of clinical nutrition2010

Effect of physiological doses of oral vitamin B12 on plasma homocysteine: a randomized, placebo-controlled, double-blind trial in India.

U S Deshmukh, C V Joglekar, H G Lubree, L V Ramdas, D S Bhat, S S Naik, P S Hardikar, D A Raut, T B Konde, A K Wills and 5 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of clinical nutrition, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 10% 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

  1. Homocysteine-lowering interventions for preventing cardiovascular events.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Trial
  3. Trial
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  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Should vitamin BAnnals of the New York Academy of Sciences · 2018
    Review
  15. Article
  16. Review
  17. Article
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  19. Article
  20. 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 4 institutions in 3 countries.

U S DeshmukhDiabetes Unit, King Edward Memorial Hospital Research Centre, Pune, Maharashtra, India.
C V Joglekar
H G Lubree
L V Ramdas
D S Bhat
S S Naik
P S Hardikar
D A Raut
T B Konde
A K Wills
A A Jackson
H Refsum
A S Nanivadekar
C H Fall
C S Yajnik
King Edward Memorial Hospital Research Centre · INUniversity of Southampton · GBSouthampton General Hospital · GBUniversity of Oxford · GB

Funding

Medical Research Council G0400519Medical Research Council MC_U147574246Medical Research Council MC_U147585821Medical Research Council MC_UP_A620_1016Wellcome Trust 059609Wellcome Trust 079877Wellcome Trust 083460
6 · The paper itself

Abstract

BACKGROUND/

objectivesVitamin B(12) (B(12)) deficiency is common in Indians and a major contributor to hyperhomocysteinemia, which may influence fetal growth, risk of type II diabetes and cardiovascular disease. The purpose of this paper was to study the effect of physiological doses of B(12) and folic acid on plasma total homocysteine (tHcy) concentration. SUBJECTS/

methodsA cluster randomized, placebo-controlled, double-blind, 2 x 3 factorial trial, using the family as the randomization unit. B(12) was given as 2 or 10 microg capsules, with or without 200 microg folic acid, forming six groups (B(0)F(0), B(2)F(0), B(10)F(0), B(0)F(200), B(2)F(200) and B(10)F(200)). Plasma tHcy concentration was measured before and after 4 and 12 months of supplementation.

resultsFrom 119 families in the Pune Maternal Nutrition Study, 300 individuals were randomized. There was no interaction between B(12) and folic acid (P=0.14) in relation to tHcy concentration change and their effects were analyzed separately: B(0) vs. B(2) vs. B(10); and F(0) vs. F(200). At 12 months, tHcy concentration reduced by a mean 5.9 (95% CI: -7.8, -4.1) micromol/l in B(2), and by 7.1 (95% CI: -8.9, -5.4) micromol/l in B(10), compared to nonsignificant rise of 1.2 (95% CI: -0.5, 2.9) micromol/l in B(0). B(2) and B(10) did not differ significantly. In F(200), tHcy concentration decreased by 4.8 (95% CI: -6.3, -3.3) micromol/l compared to 2.8 (95% CI: -4.3, -1.2) micromol/l in F(0).

conclusionDaily oral supplementation with physiological doses of B(12) is an effective community intervention to reduce tHcy. Folic acid (200 microg per day) showed no additional benefit, neither had any unfavorable effects.

Indexed as

Dietary SupplementsAdultChildDouble-Blind MethodFamilyFemaleFolic AcidHomocysteineHumansHyperhomocysteinemiaIndiaMaleVitamin B 12Vitamin B 12 DeficiencyVitamin B ComplexFolic AcidHomocysteineVitamin B 12Vitamin B Complex

Identifiers

PMID20216560
PMCPMC2865445
OpenAlexW1969636015

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.