Vegan Diet in Small Children

Study Overview
=================
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.

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

Conditions
-----------------
Vegan Diet

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 8 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vegan diet<br>Children fed vegan diet from 6 months of life | |
| Mixed diet<br>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 |