Vegan Diet in Small Children (VHS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vegan Diet

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Sweden
  • Umeå
    • Umeå, Umeå, Sweden, 90185
      • Umeå University, Department of Clinical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 8 months (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Swedish infants mainly breastfed planned for vegan or mixed diet respectively

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Vegan diet; Children fed vegan diet from 6 months of life
Mixed diet; Children fed mixed diet from 6 months of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Hemoglobin	Blood	12 months of age
Body Weight (kg)	measured weight at 12 mo using a device for measuring weight	12 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Preschool & Primary Scale of Intelligence	Scale for cognitive development. Expected mean 100. Higher scores equals better cognitive development.	3 years of age
Fat mass index	FMI, measured by DEXA-scan	3 years of age
Lean mass index	LMI, measured by DEXA-scan	3 years of age
Protein intake	3 day food diary	at 12 months of age
Fat intake	3 day food diary	at 12 months of age
Carbohydrate intake	3 day food diary	at 12 months of age
Iron intake (mg/day)	3 day food diary	throughout study
B12 levels	Serum sample	6, 12, 24, 36 months
Zink level	Serum sample	6, 12, 24, 36 months
D-vitamin levels	Serum sample	6, 12, 24, 36 months
Calcium levels	Serum sample	6, 12, 24, 36 months
Homocysteine levels	serum sample	6, 12, 24, 36 months
Transferrin receptor concentration	Serum sample	12 months of age
Transferrin saturation	serum sample	12 months of age
Mean cell volume	Blood sample	12 months of age
Ferritin	Serum sample	12 months of age
Length of body	measured length at 12 mo using measuring tool for children	12 months of age
Circumference of the head	measured at 12 mo using measuring tool for children	12 months of age

Collaborators and Investigators

• Sponsor: Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No