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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RECRUITING
60 participants
OBSERVATIONAL
2021-09-01
2029-12-31
Brief Summary
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With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets.
In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed.
The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Vegan diet
Children fed vegan diet from 6 months of life
No interventions assigned to this group
Mixed diet
Children fed mixed diet from 6 months of life
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Exclusively (\>90%) breastfed until 4 months
* Born term (GE 37+0 - 41+6)
* Single birth
* Birth weight \>2500 g
* Apgar score 5 min \> 5
Exclusion Criteria
4 Months
8 Months
ALL
Yes
Sponsors
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Umeå University
OTHER
Responsible Party
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Staffan Berglund
Senior Consultant, associate professor
Locations
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Umeå University, Department of Clinical Sciences
Umeå, , Sweden
Countries
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Facility Contacts
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Other Identifiers
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VHS
Identifier Type: -
Identifier Source: org_study_id
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