Vegan Diet in Small Children

NCT ID: NCT05442281

Last Updated: 2024-05-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2029-12-31

Brief Summary

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Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports.

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.

Detailed Description

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Conditions

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Vegan Diet

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Planned exclusive vegan diet or mixed diet respectively from 6 months of age until at least 2 years of life
* 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

\* A chronic disease affecting growth or neurodevelopment
Minimum Eligible Age

4 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Staffan Berglund

Senior Consultant, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Umeå University, Department of Clinical Sciences

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Facility Contacts

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Staffan K Berglund, MD, PhD

Role: primary

+46703956767

Other Identifiers

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VHS

Identifier Type: -

Identifier Source: org_study_id

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