Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
461 participants
INTERVENTIONAL
2023-06-16
2025-08-14
Brief Summary
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This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms.
The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy
NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception \& pregnancy
Intervention (Study Nutritional Drink)
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
Prior Control - standard micronutrients in preconception & pregnancy
NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception \& pregnancy
Control (Standard Nutritional Drink)
Control nutritional drink containing a standard mix of micronutrients
Interventions
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Intervention (Study Nutritional Drink)
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
Control (Standard Nutritional Drink)
Control nutritional drink containing a standard mix of micronutrients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
8 Years
ALL
Yes
Sponsors
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National University Hospital, Singapore
OTHER
Auckland UniServices Ltd.
INDUSTRY
Institute for Human Development and Potential (IHDP), Singapore
OTHER
National University of Singapore
OTHER
National University Health System, Singapore
OTHER
University of Auckland, New Zealand
OTHER
University of Southampton
OTHER
Responsible Party
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Principal Investigators
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Wayne S Cutfield, MB MD FRACP
Role: PRINCIPAL_INVESTIGATOR
The University of Auckland
Shiao-Yng Chan, MD PhD FRCOG
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Keith M Godfrey, BM PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
MRC Lifecourse Epidemiology Centre, University of Southampton
Locations
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The University of Auckland
Auckland, , New Zealand
National University Hospital
Singapore, , Singapore
University Hospital Southampton
Southampton, Hampshire, United Kingdom
Countries
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References
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Godfrey KM, Cutfield W, Chan SY, Baker PN, Chong YS; NiPPeR Study Group. Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial. Trials. 2017 Mar 20;18(1):131. doi: 10.1186/s13063-017-1875-x.
Godfrey KM, Barton SJ, El-Heis S, Kenealy T, Nield H, Baker PN, Chong YS, Cutfield W, Chan SY; NiPPeR Study Group. Myo-Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial. Diabetes Care. 2021 May;44(5):1091-1099. doi: 10.2337/dc20-2515. Epub 2021 Mar 29.
Other Identifiers
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79093
Identifier Type: -
Identifier Source: org_study_id
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