Vegan Diet in Small Children

Vegan Diet Clinical Trial

— VHS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442281
• Other study ID #: VHS
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2024
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 8 Months

Eligibility

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

Related Conditions & MeSH terms

• Vegan Diet

Locations

Country	Name	City	State
Sweden	Umeå University, Department of Clinical Sciences	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

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