Trial reportTrials2026
A randomized controlled double-blinded trial to assess the risk of gestational diabetes mellitus in non-anemic pregnant women who receive oral iron supplementation.
Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundPregnant women in India are routinely prescribed oral iron supplements as part of the national Anemia Mukt Bharat (AMB) program for anemia control. In women with iron-deficiency anemia, the benefits of iron supplementation during pregnancy, both for the mother and child, are very clear. In non-anemic pregnant women, however, the benefits of iron supplementation vis-à-vis associated risks that have been reported have not been studied adequately. Studies have suggested that iron may impair insulin secretion, thus increasing the risk of gestational diabetes mellitus (GDM). PRIMARY
objectiveTo determine the incidence of GDM among non-anemic pregnant women receiving 60 mg/day of elemental iron as oral supplementation, compared with those receiving 30 mg/day. SECONDARY
objectivesTo assess beta-cell functional capacity and quantify unmethylated insulin promoter DNA (a sensitive and specific marker of beta-cell damage) in blood samples from the two study groups.
methodsThis study is a randomized, parallel-group, double-blinded clinical trial, with 800 non-anemic primigravidae in each arm. One arm will receive oral supplementation at a dose of 60 mg per day (as per current national guidelines), while the other arm will receive 30 mg per day, for a duration of 12 weeks in the second trimester. The incidence of GDM in the two arms will be compared. Insulin secretion kinetics will be assessed using an oral glucose tolerance test (OGTT) done at the end of the intervention. Additionally, the unmethylated insulin promoter DNA in circulating free DNA (a marker of beta-cell damage) will be quantified in both arms. DISCUSSION: The study's findings will provide important evidence relevant to the current national guidelines in India on universal oral iron supplementation during pregnancy. The results are expected to inform future policy decisions on whether universal supplementation for all pregnant women is appropriate or whether it should be targeted to those with low iron status.
trial registrationCTRI/2024/04/065301 [registered on 05/04/2024]-trial registered prospectively.
Indexed as
Identifiers
42919408What OpenQuestion holds
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.