Clinical trial NCT05442281: Vegan Diet in Small Children
Official title: Vegan Diet in Young Children - Studies of Nutritional Intake, Growth and Neurodevelopment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vegan Diet
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Swedish infants mainly breastfed planned for vegan or mixed diet respectively

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration of Hemoglobin
timeFrame: 12 months of age
measure: Body Weight (kg)
timeFrame: 12 months of age
Secondary outcomes:
measure: Wechsler Preschool & Primary Scale of Intelligence
timeFrame: 3 years of age
measure: Fat mass index
timeFrame: 3 years of age
measure: Lean mass index
timeFrame: 3 years of age
measure: Protein intake
timeFrame: at 12 months of age
measure: Fat intake
timeFrame: at 12 months of age
measure: Carbohydrate intake
timeFrame: at 12 months of age
measure: Iron intake (mg/day)
timeFrame: throughout study
measure: B12 levels
timeFrame: 6, 12, 24, 36 months
measure: Zink level
timeFrame: 6, 12, 24, 36 months
measure: D-vitamin levels
timeFrame: 6, 12, 24, 36 months
measure: Calcium levels
timeFrame: 6, 12, 24, 36 months
measure: Homocysteine levels
timeFrame: 6, 12, 24, 36 months
measure: Transferrin receptor concentration
timeFrame: 12 months of age
measure: Transferrin saturation
timeFrame: 12 months of age
measure: Mean cell volume
timeFrame: 12 months of age
measure: Ferritin
timeFrame: 12 months of age
measure: Length of body
timeFrame: 12 months of age
measure: Circumference of the head
timeFrame: 12 months of age
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University, Department of Clinical Sciences
Study officials:
References: