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NCT Number: NCT05442281

Vegan Diet in Small Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

4 month–8 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University, Department of Clinical Sciences

Umeå, 90185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Concentration of Hemoglobin

    Time frame: 12 months of age

    Blood

  2. Body Weight (kg)

    Time frame: 12 months of age

    measured weight at 12 mo using a device for measuring weight

Secondary outcomes

  1. Wechsler Preschool & Primary Scale of Intelligence

    Time frame: 3 years of age

    Scale for cognitive development. Expected mean 100. Higher scores equals better cognitive development.

  2. Fat mass index

    Time frame: 3 years of age

    FMI, measured by DEXA-scan

  3. Lean mass index

    Time frame: 3 years of age

    LMI, measured by DEXA-scan

  4. Protein intake

    Time frame: at 12 months of age

    3 day food diary

  5. Fat intake

    Time frame: at 12 months of age

    3 day food diary

  6. Carbohydrate intake

    Time frame: at 12 months of age

    3 day food diary

  7. Iron intake (mg/day)

    Time frame: throughout study

    3 day food diary

  8. B12 levels

    Time frame: 6, 12, 24, 36 months

    Serum sample

  9. Zink level

    Time frame: 6, 12, 24, 36 months

    Serum sample

  10. D-vitamin levels

    Time frame: 6, 12, 24, 36 months

    Serum sample

  11. Calcium levels

    Time frame: 6, 12, 24, 36 months

    Serum sample

  12. Homocysteine levels

    Time frame: 6, 12, 24, 36 months

    serum sample

  13. Transferrin receptor concentration

    Time frame: 12 months of age

    Serum sample

  14. Transferrin saturation

    Time frame: 12 months of age

    serum sample

  15. Mean cell volume

    Time frame: 12 months of age

    Blood sample

  16. Ferritin

    Time frame: 12 months of age

    Serum sample

  17. Length of body

    Time frame: 12 months of age

    measured length at 12 mo using measuring tool for children

  18. Circumference of the head

    Time frame: 12 months of age

    measured at 12 mo using measuring tool for children

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Acronym: VHS

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Jul 1, 2022
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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