ArticleBMC nutrition2017
The Pune Rural Intervention in Young Adolescents (PRIYA) study: design and methods of a randomised controlled trial.
Article in BMC nutrition, 2017. 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.
What it found
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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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Maternal Vitamin B12 Status During Pregnancy and Its Association With Outcomes of Pregnancy and Health of the Offspring: A Systematic Review and Implications for Policy in India.Frontiers in endocrinology · 2021Pooled it
- Effectiveness of a complex, pre-conception intervention to reduce the risk of diabetes by reducing adiposity in young adults in Malaysia: The Jom Mama project - A randomised controlled trial.Journal of global health · 2022Trial
- Body Composition and Cardiometabolic Risk Markers in Children of Women who Took Part in a Randomized Controlled Trial of a Preconceptional Nutritional Intervention in Mumbai, India.The Journal of nutrition · 2022Trial
- Cohort profile: the Maharashtra Anaemia Study 3 (MAS 3)-a maternal-child cohort study up to age 18 years in India.BMJ open · 2025Article
- Effects of preconception nutrition interventions on pregnancy and birth outcomes in South Asia: a systematic review.The Lancet regional health. Southeast Asia · 2025Review
- Maternal Nutrition, Toxicants, and Epigenetic Programming of Obesity Across Generations.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025Review
- Generational trends in education and marriage norms in rural India: evidence from the Pune Maternal Nutrition Study.Frontiers in reproductive health · 2024Article
- Like mother like daughter, the role of low human capital in intergenerational cycles of disadvantage: the Pune Maternal Nutrition Study.Frontiers in global women's health · 2024Article
- Interventions to address global inequity in diabetes: international progress.Lancet (London, England) · 2023Article
- "Are We Feeding Them Enough?" Micronutrient Deficiency in Children Aged Six Months to Fourteen Years in India.Cureus · 2021Review
- Maternal vitamin BBMJ open · 2021Article
- Interaction between Metformin, Folate and Vitamin BInternational journal of molecular sciences · 2021Review
- Pre-conceptional Maternal Vitamin B12 Supplementation Improves Offspring Neurodevelopment at 2 Years of Age: PRIYA Trial.Frontiers in pediatrics · 2021Article
- aBMJ open · 2020Article
- Developmental undernutrition, offspring obesity and type 2 diabetes.Diabetologia · 2019Review
- Metabolic programming in early life in humans.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2019Review
- Article
- Candidate genes linking maternal nutrient exposure to offspring health via DNA methylation: a review of existing evidence in humans with specific focus on one-carbon metabolism.International journal of epidemiology · 2018Review
- Before the beginning: nutrition and lifestyle in the preconception period and its importance for future health.Lancet (London, England) · 2018Review
- Confessions of a thin-fat Indian.European journal of clinical nutrition · 2018Review
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 at 2 institutions in 2 countries.
Funding
Abstract
backgroundThe Pune Maternal Nutrition Study (PMNS) was established to prospectively study the relationship of maternal nutrition to fetal growth and later cardiometabolic risk in the offspring. High homocysteine and low vitamin B12 levels in pregnancy predicted lower birthweight and higher insulin resistance at 6 years in the offspring. B12 deficiency was widespread in this population, due to low dietary intake. We therefore commenced a community-based intervention study with the underlying hypothesis that vitamin B12 supplementation of adolescent members of the PMNS cohort will improve birth weight, B12 status, and reduce future diabetes risk, in their offspring.
methodsThe individually randomised controlled trial commenced in September 2012, with boys and girls randomized into 3 groups, to receive daily for at least 3 years or until the birth of their first child: 1) vitamin B12 2 μg; or 2) vitamin B12 2 μg plus multiple micronutrients (MMN) plus 20 g of milk powder or 3) placebo. Iron and folic acid is given to all participants. Compliance is assessed by monthly supplement counts. Adverse events are recorded using a standardised questionnaire. The primary outcome is cord blood B12 concentration; based on 180-200 pregnancies in the girls, the study has ~80% power to detect a 0.5 SD change in newborn B12, in the B12 supplementation groups compared with controls, at the 5% significance level. Primary analysis will be by intention to treat. DISCUSSION: Our study tests a primordial prevention strategy through an intergenerational intervention started pre-conceptionally in both boys and girls using physiological doses of micronutrients to improve immediate pregnancy-related and long-term cardio metabolic outcomes. The results will have significant public health implications in a setting with widespread B12 deficiency but relative folate sufficiency. The randomised controlled trial design allows us to be confident that our findings will be causally relevant.
trial registrationISRCTN 32921044, applied on 14/09/2012. CTRI 2012/12/003212, registered on 02/12/2012. Retrospectively registered.
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What 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.