The Pune Rural Intervention in Young Adolescents (PRIYA) study: design and methods of a randomised controlled trial

BMC Nutrition
Kalyanaraman KumaranChittaranjan Yajnik

Abstract

The 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. The 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...Continue Reading

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Citations

Aug 28, 2019·Diabetologia·Aryeh D SteinChittaranjan S Yajnik
May 12, 2019·BMJ : British Medical Journal·Nithya Sukumar, Ponnusamy Saravanan
Apr 11, 2019·Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences·Caroline H D Fall, Kalyanaraman Kumaran
Feb 8, 2018·European Journal of Clinical Nutrition·Chittaranjan S Yajnik
Mar 5, 2021·Diabetes Research and Clinical Practice·Bishwajit BhowmikAkhtar Hussain
Apr 22, 2021·Critical Reviews in Clinical Laboratory Sciences·Agata Sobczyńska-MaleforaDominic J Harrington

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Methods Mentioned

BETA
pregnancy test
ELISA

Clinical Trials Mentioned

ISRCTN32921044

Software Mentioned

Open Clinica
SPSS
STATA

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