Vegan Diet in Small Children

NCT05442281 | Recruiting

• 1 other identifier: VHS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vegan Diet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Wechsler Preschool & Primary Scale of Intelligence

  3 years of age

• Fat mass index

  3 years of age

• Lean mass index

  3 years of age

• Protein intake

  at 12 months of age

• Fat intake

  at 12 months of age

Study Arms (2)

Vegan diet

Children fed vegan diet from 6 months of life

Mixed diet

Children fed mixed diet from 6 months of life

Eligibility Criteria

• Age: 4 Months - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Swedish infants mainly breastfed planned for vegan or mixed diet respectively

You may qualify if:

• 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

You may not qualify if:

• \* A chronic disease affecting growth or neurodevelopment

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University, Department of Clinical Sciences

Umeå, 90185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, breast milk, whole blood

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, associate professor

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: July 1, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)