Last update May 22, 2019

Calcifediol

Compatible

Safe product and/or breastfeeding is the best option.

Vitamin D (vit. D) metabolite.
The two main forms of vit. D are vitamin D3 or cholecalciferol and vitamin D2 or ergocalciferol (SACN 2016).
Vit. D can be obtained from diet but the main source of vit. D, when there is suitable exposure to the sun, is the one formed in the dermis:
1. in the skin, via 7-dehydrocholesterol, due to the effect of ultraviolet rays (from the sun or artificial ones) vit. D3 or cholecalciferol is produced.
2. in the liver it is hydroxylated to calcifediol, also called calcidiol or 25-hydroxyvitamin D (25OHD).
3. in the kidneys it becomes hydroxyl forming calcitriol which is the natural active form and the most potent form of Vit. D in animals (SACN 2016).

Calcifediol and other vitamin D metabolites are used in the treatment and prevention of Vit. D deficiency and hypocalcemia due to hypo- or hyperparathyroid disorders. The need for Vit. D and calcium to treat hypoparathyroidism is very low during breastfeeding; it is necessary to reduce them to avoid causing hypercalcemia in mother and infant (Sweeney 2010, Caplan 1993 and 1990, Greer 1984).
An excess of vit D administration can cause toxic symptoms: hypercalcemia, hyperphosphatemia, ectopic calcifications, cardiovascular damage, fatigue, headaches, nausea and vomiting.
Vitamin D deficit causes rickets and osteomalacia.

Normal plasma levels of 25OHD are 25 to 250 nanomoles (nmol)/L (10 to 100 mcg/L) (SACN 2016). Many authors consider optimal values > 50 nmol (20 mcg)/L.
Obesity is associated with lower plasma levels in the mother and exclusively breastfed infants (Sen 2017).

A breastfeeding mother and infant’s daily Vit. D needs are 400 international units (IU) per day respectively (Sauberan 2019). Theoretically, the mother should be able to get them from her diet, the infant from being exclusively breastfed and both from exposure to sun, but this is not always the case, so it is recommended to administer 400 IU of Vit. D daily to mother and baby (SACN2016, Wagner 2008).
With limited exposure to the sun, maternal supplementation with 400 IU of Vit. D per day was not sufficient to maintain plasma levels> 20 mcg (50 nmol)/L of 25OHD neither in mothers nor infants; maternal supplementation with 1,200 IU per day did assure maternal levels of 25 OHD, but not those of infants (Czech 2014).
Therefore, some experts believe that the daily needs of Vit. D can be much higher in pregnant and breastfeeding mothers, from 2,000 to 6,400 IU per day (Hollis 2007 and 2004, Wagner 2006).

It is excreted in breast milk in tiny amounts (OPKO 2016, Fontus 2008).

Vit. D is a natural component of breast milk where it is found primarily as cholecalciferol, but also as ergocalciferol and its respective 25-hydroxylated metabolites.
The milk from the end of a feed has up to twice as much concentration of Vit. D than at the start (see Streym 2016).
The pasteurization of breast milk decreases the levels of all vitamin D metabolites by 10% to 20% (Gomes 2016).

Depending on exposure to sun, diet and supplementation, the average vitamin D content in breast milk is very variable. Without maternal supplementation it is usually <20 IU/L.
Mothers supplemented with 400 to 2,000 IU of Vit. D daily have a milk concentration of 50 to 80 IU/L (Sauberan 2019, við Streym 2016, Wagner 2006, Hollis 2004). With 4,000 IU per day, the milk levels were 130 IU/L, which is a dose of 20 IU/Kg for the baby (Hollis 2004), well below the recommended daily dose.
In Denmark the concentration of Vit. D in breast milk contributed <20% of the recommended daily dose for the infant (see Streym 2016).

Daily maternal supplementation of 6,400 IU of Vit. D achieved levels in milk between 374 and 874 IU/L, which supposed a dose of 56 to 131 UI/kg to the infant, enough to ensure the recommended daily dose (Wagner 2006).

Several guidelines for supplementation have been proposed with Vit. D3 to breastfeeding mothers during the first months and even from the last trimester of pregnancy as an alternative to direct supplementation from the infant to maintain normal Vit. D levels in infants:
- 2,000 to 6,400 IU per day (Hollis 2015, March 2015, Oberhelman 2013),
- 60,000 IU per day for 10 days in postpartum (Naik 2017),
- 100,000 to 150,000 IU per month (Wheeler 2016, Chandy 2016, Oberhelman 2013).

No clinical or biochemical abnormalities have been observed in infants whose mothers took between 400 and 6,400 IU of Vit. D per day (Hollis 2015, Czech 2014).

American Academy of Pediatrics: Vitamin D is usually compatible with breastfeeding. With high pharmacological doses, maternal and infant calcifications should be monitored (AAP 2001).

Note: divide the IU number by 40 to get the mcg.
- 40 IU = 1 mcg of Vit. D; 40,000 IU = 1 mg of Vit. D


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Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

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Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Calcifediol is also known as


Calcifediol in other languages or writings:

Group

Calcifediol belongs to this group or family:

Tradenames

Main tradenames from several countries containing Calcifediol in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 62 - 91 %
Molecular weight 419 daltons
Protein Binding > 98 %
VD 0.12 l/Kg
Tmax 4 hours
264 - 288 hours

References

  1. Sauberan JB. High-Dose Vitamins. Breastfeed Med. 2019 Apr 30. Abstract
  2. Naik P, Faridi MMA, Batra P, Madhu SV. Oral Supplementation of Parturient Mothers with Vitamin D and Its Effect on 25OHD Status of Exclusively Breastfed Infants at 6 Months of Age: A Double-Blind Randomized Placebo Controlled Trial. Breastfeed Med. 2017 Abstract
  3. Sen S, Penfield-Cyr A, Hollis BW, Wagner CL. Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr. 2017 Abstract
  4. Wheeler BJ, Taylor BJ, Herbison P, Haszard JJ, Mikhail A, Jones S, Harper MJ, Houghton LA. High-Dose Monthly Maternal Cholecalciferol Supplementation during Breastfeeding Affects Maternal and Infant Vitamin D Status at 5 Months Postpartum: A Randomized Controlled Trial. J Nutr. 2016 Abstract
  5. SACN. Vitamin D and Health. 2016 Full text (link to original source) Full text (in our servers)
  6. við Streym S, Højskov CS, Møller UK, Heickendorff L, Vestergaard P, Mosekilde L, Rejnmark L. Vitamin D content in human breast milk: a 9-mo follow-up study. Am J Clin Nutr. 2016 Abstract
  7. Gomes FP, Shaw PN, Whitfield K, Koorts P, McConachy H, Hewavitharana AK. Effect of pasteurisation on the concentrations of vitamin D compounds in donor breastmilk. Int J Food Sci Nutr. 2016 Abstract
  8. Chandy DD, Kare J, Singh SN, Agarwal A, Das V, Singh U, Ramesh V, Bhatia V. Effect of vitamin D supplementation, directly or via breast milk for term infants, on serum 25 hydroxyvitamin D and related biochemistry, and propensity to infection: a randomised placebo-controlled trial. Br J Nutr. 2016 Abstract
  9. OPKO. Calcifediol. Drug Summary. 2016 Full text (in our servers)
  10. AEMPS. Calcifediol. Ficha técnica. 2015 Full text (in our servers)
  11. March KM, Chen NN, Karakochuk CD, Shand AW, Innis SM, von Dadelszen P, Barr SI, Lyon MR, Whiting SJ, Weiler HA, Green TJ. Maternal vitamin D₃ supplementation at 50 μg/d protects against low serum 25-hydroxyvitamin D in infants at 8 wk of age: a randomized controlled trial of 3 doses of vitamin D beginning in gestation and continued in lactation. Am J Clin Nutr. 2015 Abstract
  12. Hollis BW, Wagner CL, Howard CR, Ebeling M, Shary JR, Smith PG, Taylor SN, Morella K, Lawrence RA, Hulsey TC. Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics. 2015 Abstract
  13. Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, Chazan B, Pawlus B, Zochowska A, Borszewska-Kornacka MK, Karczmarewicz E, Czekuc-Kryskiewicz E, Dobrzanska A. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLoS One. 2014 Abstract
  14. Oberhelman SS, Meekins ME, Fischer PR, Lee BR, Singh RJ, Cha SS, Gardner BM, Pettifor JM, Croghan IT, Thacher TD. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clin Proc. 2013 Abstract
  15. Sweeney LL, Malabanan AO, Rosen H. Decreased calcitriol requirement during pregnancy and lactation with a window of increased requirement immediately post partum. Endocr Pract. 2010 Abstract
  16. Wagner CL, Greer FR; American Academy of Pediatrics Section on Breastfeeding.; American Academy of Pediatrics Committee on Nutrition.. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008 Abstract
  17. Fontus. Calcitriol. Drug Summary. 2008 Full text (in our servers)
  18. Hollis BW. Vitamin D requirement during pregnancy and lactation. J Bone Miner Res. 2007 Abstract
  19. Wagner CL, Hulsey TC, Fanning D, Ebeling M, Hollis BW. High-dose vitamin D3 supplementation in a cohort of breastfeeding mothers and their infants: a 6-month follow-up pilot study. Breastfeed Med. 2006 Abstract
  20. Hollis BW, Wagner CL. Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant. Am J Clin Nutr. 2004 Abstract
  21. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  22. Caplan RH, Wickus GG. Reduced calcitriol requirements for treating hypoparathyroidism during lactation. A case report. J Reprod Med. 1993 Abstract
  23. Caplan RH, Beguin EA. Hypercalcemia in a calcitriol-treated hypoparathyroid woman during lactation. Obstet Gynecol. 1990 Abstract
  24. Greer FR, Hollis BW, Napoli JL. High concentrations of vitamin D2 in human milk associated with pharmacologic doses of vitamin D2. J Pediatr. 1984 Abstract

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