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Vegan Diet in Small Children

Vegan Diet in Young Children - Studies of Nutritional Intake, Growth and Neurodevelopment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05442281
Acronym
VHS
Enrollment
60
Registered
2022-07-01
Start date
2021-09-01
Completion date
2029-12-31
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vegan Diet

Brief summary

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.

Interventions

None listed

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Months to 8 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of Hemoglobin12 months of ageBlood
Body Weight (kg)12 months of agemeasured weight at 12 mo using a device for measuring weight

Secondary

MeasureTime frameDescription
Wechsler Preschool & Primary Scale of Intelligence3 years of ageScale for cognitive development. Expected mean 100. Higher scores equals better cognitive development.
Fat mass index3 years of ageFMI, measured by DEXA-scan
Lean mass index3 years of ageLMI, measured by DEXA-scan
Protein intakeat 12 months of age3 day food diary
Fat intakeat 12 months of age3 day food diary
Carbohydrate intakeat 12 months of age3 day food diary
Iron intake (mg/day)throughout study3 day food diary
B12 levels6, 12, 24, 36 monthsSerum sample
Zink level6, 12, 24, 36 monthsSerum sample
D-vitamin levels6, 12, 24, 36 monthsSerum sample
Calcium levels6, 12, 24, 36 monthsSerum sample
Homocysteine levels6, 12, 24, 36 monthsserum sample
Transferrin receptor concentration12 months of ageSerum sample
Transferrin saturation12 months of ageserum sample
Mean cell volume12 months of ageBlood sample
Ferritin12 months of ageSerum sample
Length of body12 months of agemeasured length at 12 mo using measuring tool for children
Circumference of the head12 months of agemeasured at 12 mo using measuring tool for children

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026