Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Cholecalciferol (vitamin D)

Generic name
Cholecalciferol (vitamin D)
Brand name
ATC Code
A11CC05

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Prophylaxis vitamin D deficiency, treatment of vitamin D deficiency (25(OH)D levels ≥30 nmol/l) (DUTCH INDICATION DUE TO AVAILABILITY OF FORMULATIONS)
  • Oral
    • Premature infants Gestational age < 37 weeks and < 1250 g
      [2] [5] [6]
      • 600 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Premature infants Gestational age < 37 weeks and ≥ 1250 g
      [2] [5] [6]
      • 400 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Term neonate
      [2] [5] [6] [20] [24]
      • 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
    • 1 month up to 4 years
      [2] [5] [6] [20] [24]
      • 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
    • 4 years up to 18 years
      [19]
      • 400 - 600 IU/day in 1 dose in children that have an increased risk for vitamin D deficiency. For children with dark coloured skin: 800 IE/day.
Supplementation in cystic fibrosis
  • Oral
    • 1 month up to 2 years
      [3] [18] [23]
      • Initial dose: 400 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevel to 400 - 1.000 IU/day in 1 dose
    • 2 years up to 4 years
      [18] [23]
      • Initial dose: 400 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevels to 400 - 2.000 IU/day in 1 dose
    • 4 years up to 10 years
      [18] [23]
      • Initial dose: 600 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevels to  600 - 2.000 IU/day in 1 dose
    • 10 years up to 18 years
      [18] [23]
      • Initial dose: 600 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevels to 600 - 4.000 IU/day in 1 dose
Treatment of vitamin D deficiency (25(OH)D spiegel <30 nmol/l)(DUTCH INDICATION DUE TO AVAILABILITY OF FORMULATIONS)
  • Oral
    • Premature neonates Gestational age < 37 weeks and < 1250 g
      [6]
      • 600 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Preterm neonates Gestational age < 37 weeks and ≥ 1250 g
      [6]
      • 400 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Term neonates 0 months up to 3 months
      [4] [6] [7] [20] [21] [26]
      • Initial dose: 2.000 IU/day in 1 dose for 3 months.
      • Maintenance dose: 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day..

      • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.

    • 3 months up to 1 year
      [20] [21] [22] [25] [26]
      • Initial dose: 2.000 IU/day in 1 dose For 3 months.

        .
      • Maintenance dose: 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
        • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.
        • As an alternative to a daily initial dose, a single high dose (50,000 IU/dose) may be considered in individual cases. Then, after 3 months, check whether the 25(OH)D level has normalized and, if so, continue with the maintenance dose. 
    • 1 year up to 12 years
      [20] [25]
      • Initial dose: 3.000 - 6.000 IU/day in 1 dose For 3 months.

        .
      • Maintenance dose: 600 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
        • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.
        • As an alternative to a daily initial dose, a single high dose (150.000 IU/dose) may be considered in individual cases. Then, after 3 months, check whether the 25(OH)D level has normalized and, if so, continue with the maintenance dose. 

         

    • 12 years up to 18 years
      [20]
      • Initial dose: 6.000 IU/day in 1 dose For 3 months.

        .
      • Maintenance dose: 600 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
        • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.
        • As an alternative to a daily initial dose, a single high dose (300.000 IU/dose) may be considered in individual cases. Then, after 3 months, check whether the 25(OH)D level has normalized and, if so, continue with the maintenance dose. 

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Gastro-intestinal symptoms (Holmlund-Suila 2012).

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Risk factors for a vitamin D deficiency are insufficient sun exposure (in the Netherlands from October to April, city and indoor living, clothing, sunscreen), insufficient production of vitamin D in the skin (dark skin, old age, chronic illness), high volume of distribution at obesity, pregnancy, celiac disease, bariatric surgery, impaired renal function and some drugs (including anti-epileptics, tuberculostatics) (Aguirre Castaneda 2012, Öhlund 2017, Rajakumar 2016). Symptoms of vitamin D deficiency can also occur in premature babies, infants who are exclusively breastfed for more than six months without receiving calcium-containing food and children who are strictly vegetarian. [SmPC Dekristolmin 12/2018]

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Vitamin A, plain
A11CA01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Gezondheidsraad, Evaluatie van de voedingsnormen voor vitamine D, Den Haag, 2012, pu­bli­ca­tienr. 2012/15
  3. Kneepkens CMF et al, Werkboek Kindergastro-Enterologie, VU Uitgeverij, 2002, 2e druk
  4. Noordam C et al, Werkboek Kinderendocrinologie, digitale publicatie op www.nvk.nl (alleen leden), 2010
  5. Het voedingscentrum, Rapportage consultatieronde vitamine D- suppletieadviezen, www.voedingscentrum.nl, Mei 2011, http://www.voedingscentrum.nl/Assets/Uploads/Documents/Voedingscentrum/Professionals/Rapport%20consultatieronde%20vitamine%20D%20DEF.pdf
  6. Lafeber H. et al, NVK Werkboek enterale en parenterale voeding van pasgeborenen, VU Uitgeverij, 2012
  7. Laboratories SMB S.A., SmPC D-Cura 2400 IE (RVG 112993) 11-03-2015, www.geneesmiddeleninformatiebank.nl
  8. Merck, SmPC Vigantoletten 500 IE, 1.000 IE (6154298.00.00/ 6154298.01.00), 02/ 2017
  9. mibe, SmPC Dekristol® 20 000 I.E. (3000309.00.00), 09/2015
  10. Hexal, SmPC Vitamin D-Sandoz® 500 / 1000 I.E. Tabletten (91571.00.00 / 91571.00.00), 03/2017
  11. Pädia, SmPC DeVit® Tropfen 2400 I.E. (94267.00.00), 07/2015
  12. mibe, SmPC Dekristol 400IE Tabletten (3000424.00.00), 09/2015
  13. Merck, SmPC Vigantol Öl 20.000 IE/ml Lösung (6154275.00.01), 12/2015
  14. Rajakumar R et al. , Effect of Vitamin D3 Supplementation in Black and in White Children: A Randomized, Placebo-Controlled Trial., J Clin Endocrinol Metab. , 2015, Aug;100(8), 3183-92
  15. Öhlund I et al. , Increased vitamin D intake differentiated according to skin color is needed to meet requirements in young Swedish children during winter: a double-blind randomized clinical trial, Am J Clin Nutr, 2017, Jul;106(1), 105-112
  16. Aguirre Castaneda R et al, Response to Vitamin D3 Supplementation in Obese and Nonobese Caucasian Adolescents, Horm Res Paediatr, 2012, 78(4), 226-31
  17. Holmlund-Suila E., High-dose vitamin d intervention in infants--effects on vitamin d status, calcium homeostasis, and bone strength, J Clin Endocrinol Metab, 2012, 97(11), 4139-47
  18. Turck, D et al, ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis, Clin NUtr, 2016, 35(3), 557-77
  19. Ross, A. C et al, The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know, J Clin Endocrinol Metab, 2011, 96 (1), 53-8
  20. Munns, C. F. et al, Global Consensus Recommendations on Prevention and Management of Nutritional Rickets, J Clin Endocrinol Metab, 2016, 101 (2), 394-415
  21. Kruse, K. , Pathophysiology of calcium metabolism in children with vitamin D-deficiency rickets, J Pediatr, 1995, 126 (5 Pt 1), 736-41
  22. Gordon, C. M. et al, Treatment of hypovitaminosis D in infants and toddlers, J Clin Endocrinol Metab, 2008, 93 (7), 2716-21
  23. Gijsbers, C.F.M. et al , Werkboek Kindermaag-darm-leverziekten. Derde druk, VU Uitgeverij www.nvk.nl, 2014
  24. Gallo, S.. et al , Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial., JAMA, 309(17), 1785-92
  25. Emel, T. et al , Therapy strategies in vitamin D deficiency with or without rickets: efficiency of low-dose stoss therapy, J Pediatr Endocrinol Metab, 2012, 25 (1-2), 107-10
  26. Cesur, Y. et al, Comparison of low and high dose of vitamin D treatment in nutritional vitamin D deficiency rickets., J Pediatr Endocrinol Metab, 2003, 16(8), 1105-9

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Changes

Changes