Babytol ® D3 for you! twist-off capsules represent an additional source of vitamin D3 (cholecalciferol), intended for use in infants and children.
Vitamin D3 is an essential fat-soluble vitamin that has a key role in the regulation of calcium and phosphorus metabolism. Its primary biological function is to contribute to the normal absorption and utilization of these minerals from the digestive tract, thereby enabling their proper incorporation into bone tissue.
Adequate mineralization of bones in the earliest age is of essential importance for the formation of a strong skeleton during childhood. Due to intensive growth during the first year of life and early childhood, vitamin D3 represents an important nutritional factor for supporting the normal development of the skeletal system.
According to regulatory approved health claims of the European Union, vitamin D contributes to the normal absorption and utilization of calcium and phosphorus, as well as to the normal growth and development of bones in children. These claims are based on the scientific assessment of the European Food Safety Authority (EFSA) and are officially registered in the EU Register of nutrition and health claims.
In addition, vitamin D has a role in cell division, normal muscle function, normal function of the immune system in children, and the maintenance of normal teeth.
Source
Regulatory source (authorized health claims):
Commission Regulation (EU) No 432/2012. Establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health. Official Journal of the European Union. 2012. Regulation by which health claims have been authorized, including that vitamin D contributes to the normal absorption/utilization of calcium and phosphorus, as well as to the normal growth and development of bones in children.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0432
Vitamin D3 (cholecalciferol) is synthesized in the body in the skin under the influence of ultraviolet B (UVB) radiation from sunlight. During exposure to UVB rays, 7-dehydrocholesterol in the epidermis is converted into pre-vitamin D3, which is then spontaneously transformed into vitamin D3 and further metabolically activated in the liver and kidneys. This synthesis mechanism is described in detail in the review by Holick (New England Journal of Medicine, 2007). Due to this physiological production, vitamin D is often referred to as the “sunshine vitamin”.
However, the amount of vitamin D that can be produced in the skin depends on multiple factors, including season, time of day, intensity and angle of solar radiation, skin color, surface area of exposed skin, age, as well as the use of protective products with a UV factor. During the winter months, the intensity of UVB radiation may be insufficient for adequate vitamin D synthesis, as highlighted in expert reviews on vitamin D metabolism.
Public health institutions, including the Centers for Disease Control and Prevention (CDC), state that infants younger than 12 months require a daily intake of 400 IU of vitamin D. In pediatric practice, vitamin D supplementation represents a standard approach to ensuring a consistent daily intake in infants and young children, taking into account limited exposure to direct sunlight and variability of endogenous synthesis.
In addition to CDC guidelines, the same reference framework is provided by ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology and Nutrition) and NIH (National Institutes of Health, Office of Dietary Supplements) - and they recommend supplementation of 400 IU daily during the first year of life.
Sources
Holick MF. Vitamin D deficiency. New England Journal of Medicine. 2007;357(3):266–281. Review article that analyzes the causes, diagnostics and clinical consequences of vitamin D deficiency, including its impact on calcium metabolism, bone health, rickets, osteomalacia and potential non-skeletal effects.
https://www.nejm.org/doi/full/10.1056/NEJMra070553
Centers for Disease Control and Prevention (CDC). Vitamin D | Infant and Toddler Nutrition. Expert guidelines on recommended vitamin D intake in infants and young children, including a recommendation of 400 IU (10 µg) daily for children younger than 12 months and supplementation guidance depending on intake from food or formula.
https://www.cdc.gov/infant-toddler-nutrition/vitamins-minerals/vitamin-d.html
Braegger C, Campoy C, Colomb V, Decsi T, Domellöf M, Fewtrell M, et al.; ESPGHAN Committee on Nutrition. Vitamin D in the Healthy European Paediatric Population. Journal of Pediatric Gastroenterology and Nutrition. 2013;56(6):692–701. doi:10.1097/MPG.0b013e31828f3c05. This position paper states that all infants should receive oral supplementation of 400 IU of vitamin D daily during the first year of life.
National Institutes of Health, Office of Dietary Supplements. Vitamin D – Health Professional Fact Sheet. Bethesda, MD: NIH Office of Dietary Supplements; updated June 27, 2025. This official NIH review states a recommended intake of 10 mcg (400 IU) for infants 0–6 and 7–12 months.
Vitamin D3 (cholecalciferol) participates in the regulation of calcium and phosphorus metabolism by contributing to their normal absorption and utilization in the digestive tract. In this way, it enables these minerals to be efficiently used in mineralization processes – that is, the incorporation of mineral components into the hard tissues of the body.
In children, this mechanism is particularly important because in early age two intensive processes take place simultaneously: the formation and growth of the skeleton, as well as the development of teeth. Calcium and phosphorus are the basic mineral components of bone tissue, while in teeth they are key for the mineralization of dental structures, including hard tissues that provide their strength and resistance.
Vitamin D3 contributes to the maintenance of normal calcium levels in the blood, which is a prerequisite for the body to have a sufficient amount of minerals for these processes. In practice, when the absorption of calcium and phosphorus is adequate, the body has a better basis to support the physiological formation of the skeletal system and the mineralization of teeth during development.
According to regulatory approved health claims of the European Union, vitamin D contributes to the normal absorption and utilization of calcium and phosphorus, as well as to the maintenance of normal bones and teeth. These claims are based on the scientific assessment of the European Food Safety Authority (EFSA) and are registered in the EU Register of nutrition and health claims.
Source (authorized health claims)
Commission Regulation (EU) No 432/2012. Establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. Official Journal of the European Union. 2012. Regulation by which health claims are authorized including that vitamin D contributes to the normal absorption/utilization of calcium and phosphorus, maintenance of normal bones and maintenance of normal teeth.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0432
Vitamin D3 (cholecalciferol) plays a significant role in the regulation of the immune system in children. Over the past several decades, research has shown that vitamin D participates in the modulation of both innate and adaptive immune responses, influencing the activity of various immune cells, including monocytes, macrophages, and lymphocytes. This immunomodulatory role has been analyzed in detail in the review by Martens et al. (Nutrients, 2020).
Vitamin D receptors (VDR) are present in numerous cells of the immune system, including cells active during early childhood development, indicating its regulatory role in immunological processes. Scientific reviews state that adequate vitamin D status contributes to normal immune response function, while its deficiency is associated with disturbances in immune regulation, including in the pediatric population (Martens et al., 2020).
According to regulatory-approved health claims of the European Union, vitamin D contributes to the normal function of the immune system. This claim is based on the scientific assessment of the European Food Safety Authority (EFSA) and is registered in the EU Register of nutrition and health claims (Commission Regulation (EU) No 432/2012).
Sources
Commission Regulation (EU) No 432/2012. Establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. Official Journal of the European Union. 2012.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0432
Martens PJ, Gysemans C, Verstuyf A, Mathieu C. Vitamin D’s Effect on Immune Function. Nutrients. 2020;12(5):1248.
https://pmc.ncbi.nlm.nih.gov/articles/PMC7281985/
Vitamin D3 (cholecalciferol) represents a form of vitamin D that is used in pediatric supplementation. Professional pediatric associations recommend routine supplementation with vitamin D from the earliest age. The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends the use of vitamin D at a dose of 400 IU (10 µg) daily during the first year of life, regardless of the method of infant feeding.
This recommendation is based on the assessment that vitamin D intake through diet in early age is often not sufficient to ensure optimal nutritional status, which may have consequences for bone mineralization and skeletal development. Routine supplementation has been introduced as a preventive measure to support normal growth and development of the skeletal system during the period of intensive development.
After the first year of life, the recommended daily intake of vitamin D in most pediatric guidelines remains in the range of at least 400 IU daily, depending on age and individual needs of the child. Continuous use during early childhood is assessed in accordance with pediatric advice and current professional recommendations.
Source
ESPGHAN Committee on Nutrition. Vitamin D in the healthy European paediatric population. Journal of Pediatric Gastroenterology and Nutrition. 2013;56(6):692–701. Position paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) which recommends routine supplementation of vitamin D at a dose of 400 IU (10 µg) daily during the first year of life, regardless of feeding method, for the prevention of deficiency and support of normal bone mineralization.
https://pubmed.ncbi.nlm.nih.gov/23708639/
Vitamin D3 (cholecalciferol) – absorption of calcium and support for bones and teeth
Vitamin D3 (cholecalciferol) is a form of vitamin D that is naturally synthesized in the skin under the influence of UVB radiation, which is why it is often called the “sunshine vitamin”. In the body, it has a key role in the regulation of calcium and phosphorus metabolism.
Vitamin D contributes to the normal absorption and utilization of calcium and phosphorus from the digestive tract, thereby supporting the mineralization of bone tissue and the normal development of bones and teeth in children.
According to regulatory approved health claims of the European Union, vitamin D contributes to the normal absorption/utilization of calcium and phosphorus, as well as to the maintenance of normal bones and teeth.
In addition, vitamin D has a role in cell division, normal muscle function, normal function of the immune system in children and the maintenance of normal teeth.
Source
Regulatory source (authorized health claims):
Commission Regulation (EU) No 432/2012. Establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health. Official Journal of the European Union. 2012. Regulation by which health claims have been authorized, including that vitamin D contributes to the normal absorption/utilization of calcium and phosphorus, as well as to the normal growth and development of bones in children.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0432
Olive oil – lipid base for vitamin D3
Vitamin D3 is a fat-soluble vitamin, which means that it dissolves in fats and that its absorption in the digestive tract takes place in the presence of lipids. For this reason, vitamin D3 in this product is dissolved in olive oil, which provides an appropriate lipid medium for its stability and physiological absorption.
The use of olive oil as a plant-based lipid base enables uniform distribution of vitamin D3 in the capsule and convenient use in infants and children.
The simplest way of administering – twist-off capsule
Babytol ® D3 uses individually dosed twist-off capsules that enable simple, precise and hygienic use in infants and children.
The capsule is opened by gently twisting and removing the upper part, after which the content is squeezed directly into the baby’s mouth or into a spoon. This method of use eliminates the need for measuring drops and reduces the possibility of dosing errors.
Individual packaging ensures that the child receives a precisely defined amount of vitamin D3 with each use, in accordance with the recommended daily dose.
Administration of vitamin D3 from the eighth day of life – daily during the first year
Professional pediatric guidelines recommend routine supplementation with vitamin D from the earliest age. According to the position paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), the recommended daily intake of vitamin D is 400 IU (10 µg) during the first year of life, regardless of the method of feeding.
In clinical practice, supplementation is initiated in the earliest postnatal period, most often from the eighth day of life, and is administered daily, regardless of the method of feeding of the child. This regimen of use aims to maintain an adequate nutritional status of vitamin D during the period of intensive growth.
After the first year of life, continuation of use is assessed individually, in accordance with pediatric advice and current professional recommendations.
Source
ESPGHAN Committee on Nutrition. Vitamin D in the healthy European paediatric population. Journal of Pediatric Gastroenterology and Nutrition. 2013;56(6):692–701. Position paper that provides recommendations for vitamin D intake in the healthy European paediatric population, including routine supplementation of 400 IU (10 µg) daily during the first year of life for the prevention of deficiency and support of normal bone mineralization.
https://pubmed.ncbi.nlm.nih.gov/23708639/
Adequate daily intake of vitamin D is of essential importance in early age, as it contributes to the normal growth and development of bones, mineralization of the skeleton and maintenance of an adequate nutritional status during the period of intensive development.
According to the guidelines stated by the Centers for Disease Control and Prevention (CDC), children younger than 12 months require a daily intake of 400 IU (10 µg) of vitamin D. For children aged 12 to 24 months, the recommended daily intake is 600 IU (15 µg). These values refer to the total daily intake of vitamin D from all sources – diet and supplementation.
Recommendations for the prevention of vitamin D deficiency and rickets (a disorder of mineralization and bone development in children, which occurs when the body does not have enough vitamin D and therefore cannot properly utilize calcium and phosphorus needed for bone growth) are further defined in professional guidelines of the American Academy of Pediatrics (AAP), published by Wagner and Greer (2008). These guidelines recommend that all infants, children and adolescents have a minimum daily intake of 400 IU (10 µg) of vitamin D, starting shortly after birth. This measure has been introduced as a preventive strategy with the aim of reducing the risk of rickets and maintaining an adequate vitamin D status during growth and development.
The guidelines also emphasize the importance of timely supplementation in children in whom intake through diet is not sufficient to provide the recommended amounts of vitamin D, especially in infants who are exclusively breastfed.
Source
Centers for Disease Control and Prevention (CDC). Vitamin D | Infant and Toddler Nutrition. Official guidelines on the recommended daily intake of vitamin D in infants and young children, including a recommendation of 400 IU (IU) daily for children younger than 12 months and 600 IU (IU) daily for children aged 12 to 24 months, as well as information on supplementation and prevention of vitamin D deficiency.
https://www.cdc.gov/infant-toddler-nutrition/vitamins-minerals/vitamin-d.html
Wagner CL, Greer FR. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008 Nov;122(5):1142–1152. Professional guidelines of the American Academy of Pediatrics that define recommendations for the prevention of rickets and vitamin D deficiency in infants, children and adolescents, including the recommended daily intake of vitamin D, indications for supplementation and identification of risk groups.
doi: 10.1542/peds.2008-1862
https://publications.aap.org/pediatrics/article/122/5/1142/71470/Prevention-of-Rickets-and-Vitamin-D-Deficiency-in
The role of vitamin D in the immune system has been the subject of intensive research over the past decades. In the review by Martens et al. (2020), it is described in detail that the vitamin D receptor (VDR) is expressed in various cells of the innate and adaptive immune system, including monocytes, macrophages, dendritic cells, and T and B lymphocytes. This expression indicates its regulatory role in immunological signaling pathways.
Vitamin D participates in the modulation of cytokine response and differentiation of immune cells, thereby contributing to the maintenance of immune homeostasis. The authors state that an adequate vitamin D status is important for proper functioning of the immune system, while severe deficiency is associated with disturbances in immune regulation and increased incidence of autoimmune conditions in epidemiological observations.
Source
Martens PJ, Gysemans C, Verstuyf A, Mathieu AC. Vitamin D’s Effect on Immune Function. Nutrients. 2020 Apr 28;12(5):1248. Review article that analyzes the mechanisms of action of vitamin D in the immune system, including immunomodulatory effects on innate and adaptive immune response, impact on cytokine production and function of immune cells.
doi: 10.3390/nu12051248; PMID: 32353972; PMCID: PMC7281985
https://pmc.ncbi.nlm.nih.gov/articles/PMC7281985/
Vitamin D deficiency is not present in every child, but in infancy and early childhood it is sufficiently common to require special attention. This is contributed to by limited dietary intake, variable and often insufficient synthesis in the skin due to limited exposure to sunlight, as well as the fact that breast milk itself usually does not provide an amount of vitamin D sufficient to meet the daily needs of the infant (with the note that breast milk undoubtedly remains the best food for the baby and should not be discontinued). The risk may be additionally higher in children with darker skin pigmentation, lower exposure to sunlight and in conditions that impair fat absorption, which is why in pediatric practice the importance of timely supplementation is emphasized, especially in the first year of life.
Source
Wagner, C. L., & Greer, F. R. (2008). Prevention of Rickets and Vitamin D Deficiency in Infants, Children, and Adolescents. Pediatrics, 122(5). [DOI: 10.1542/peds.2008-1862] This study represents the official position of the American Academy of Pediatrics (AAP) and explains that breast milk does not contain enough vitamin D, which is why supplementation of 400 IU daily from the first days of life is mandatory (with the note that breast milk remains the gold standard of infant nutrition). https://pubmed.ncbi.nlm.nih.gov/1897799/
Braegger, C., et al. (2013). Vitamin D Recommendations for Infants and Children. ESPGHAN Position Paper. European guidelines indicate the risks of deficiency in early age and recommend mandatory supplementation while maintaining breastfeeding as the basis of healthy development. https://pubmed.ncbi.nlm.nih.gov/23708639/
Munns, C. F., et al. (2016). Global Consensus Recommendations on Prevention and Management of Nutritional Rickets. The Journal of Clinical Endocrinology & Metabolism. [DOI: 10.1210/jc.2015-2175] This global expert consensus emphasizes that skin pigmentation and modern factors (lack of sunlight exposure) make supplementation a necessary preventive measure in pediatrics worldwide. https://pubmed.ncbi.nlm.nih.gov/2674525/
Please note that the referenced clinical studies and scientific sources relate to individual product ingredients and their effects, not to the product as a whole.
Vitamin D3 is administered from day 8 of life, in accordance with European and national recommendations of pediatricians, for healthy bone development in children at a dose of 400 IU per day.
Vitamin D is important for the normal absorption and utilization of calcium and phosphorus.
The recommended dose of vitamin D3 for all newborns is 400 IU and is mandatory from the second week until the age of one year. This recommended dose is contained in one twist – off capsule of Babytol D3.
Mandatory supplementation according to all European and national recommendations applies from the 8th day of life, daily, until the age of one year. After one year, supplementation at a dose of 400 IU per day is advised, in the winter months (from October to March)
Vitamin D3 is dissolved in allergen-free olive oil, which allows for better absorption and utilization. Vitamin D3 is liposoluble and dissolves in oil, so absorption and utilization is much better.
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