Vegan Diet in Small Children

Recruiting

• Conditions: Vegan Diet

• Registration Number: NCT05442281
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of Hemoglobin	12 months of age	Blood
Body Weight (kg)	12 months of age	measured weight at 12 mo using a device for measuring weight

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Umeå University, Department of Clinical Sciences; 🇸🇪 Umeå, Sweden