
Calcitriol is a synthetic form of vitamin D3 used to treat low levels of calcium in the blood. It is also used to treat hyperparathyroidism, metabolic bone disease, and calcium deficiency. While it is a prescription medication, there is uncertainty about its use during pregnancy due to potential risks to the fetus. Animal studies have shown adverse effects, including external and skeletal abnormalities, decreased fetal weight, reduced newborn survival, and maternal mortality at high doses. However, the significance of these findings in humans is uncertain, and there are limited data available. The decision to use calcitriol during pregnancy should be carefully evaluated, weighing the potential benefits against the risks to the unborn child.
What You'll Learn
Calcitriol treats low calcium in the blood
Calcitriol is a medication that treats low calcium levels in the blood caused by kidney disease or poorly functioning parathyroid glands. It is a synthetic vitamin D analog, which means it is a synthetic version of vitamin D. It works by increasing the amount of calcium in the body and helping to regulate parathyroid hormone levels.
Calcitriol is available in capsule, oral solution, injectable, and ointment forms. When taken orally, it is usually taken once a day or once every other day with or without food. It is important to follow the directions on the prescription label and not to take more or less than what is prescribed.
While calcitriol is effective in treating low calcium levels, it is important to note that it should be used with caution during pregnancy. Animal studies have shown that high doses of calcitriol can cause maternal mortality, decreased fetal weight, reduced newborn survival, and hypercalcemia in the offspring. There are no well-controlled studies in humans, but the potential benefits may outweigh the risks in pregnant women. However, close monitoring of serum calcium levels is required during pregnancy as alterations in calcium production, metabolism, and excretion can occur.
In addition to treating low calcium levels, calcitriol is also used to treat plaque psoriasis and prevent corticosteroid-induced osteoporosis. It is important to follow the diet given by your doctor when taking calcitriol and to avoid antacids that contain magnesium.
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Calcitriol is a synthetic form of vitamin D3
Calcitriol works by binding to and activating the vitamin D receptor in the cell nucleus, increasing the expression of genes involved in calcium transport. It promotes the absorption of dietary calcium from the intestines, increases its reabsorption in the kidneys, and stimulates its release from bone. These actions help maintain adequate calcium levels in the body, which is particularly important for bone health.
Calcitriol is available as a prescription medication and is used to treat various conditions related to calcium deficiency and bone health. It can be taken orally or injected directly into a vein. Common side effects include weakness, fatigue, nausea, and headache.
Regarding its use during pregnancy, calcitriol is categorised as a 'C' drug by the FDA, meaning that animal studies have shown adverse effects on the foetus, but there are no well-controlled studies in humans. Therefore, the benefit to the mother should outweigh the potential risks to the unborn child. Animal studies have shown external and skeletal abnormalities, as well as decreased foetal weight, reduced newborn survival, and hypercalcemia in offspring when given high doses of calcitriol. However, in humans, there is limited data, and the drug should be used during pregnancy only if the benefits outweigh the risks.
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Animal studies showed external and skeletal abnormalities
Animal studies have shown external and skeletal abnormalities in some studies, but not in others. High doses of calcitriol (about six times the maximum human dose) have been shown to cause maternal mortality, decreased foetal weight, reduced newborn survival, and hypercalcemia in the offspring. In addition, fetuses with supravalvular aortic stenosis have been observed with near-fatal doses.
However, it is important to note that the significance of these findings in humans is uncertain. While animal studies have shown evidence of increased fetal damage, there are no controlled data in human pregnancy. The available data on topical, oral, and intravenous exposure during pregnancy have not identified an increased risk of major birth defects, miscarriages, or adverse fetal or maternal effects.
In one study, oral administration of up to 0.9 mg/kg/day of calcitriol did not show any effects on fetal or reproductive parameters. On the other hand, topical administration (3 ppm) to 6.4% of the body surface area resulted in significantly elevated mean post-implantation loss and minor skeletal abnormalities from delayed ossification of the pubic bones. This suggests that the route of administration may play a role in the effects observed.
Another study reported the successful treatment of a pregnant woman with hypoparathyroidism using calcitriol. The woman gave birth to healthy twin infants at 37 weeks via cesarean section. Laboratory investigations during the perinatal period revealed normal serum calcium and phosphorus levels in the mother and no clinical or biochemical signs of hyperparathyroidism in the infants.
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High doses of calcitriol caused maternal mortality in animal studies
Animal studies have shown that high doses of calcitriol can cause maternal mortality. In particular, doses approximately six times the maximum human dose have been found to cause maternal death, along with decreased foetal weight, reduced newborn survival rates, and hypercalcemia in the offspring. Fetuses with supravalvular aortic stenosis have also been observed in cases where pregnant animals were given near-fatal doses.
The effects of calcitriol on human pregnancies are not well understood. There are no controlled data on the use of calcitriol in human pregnancies, and the drug is categorised as a US FDA pregnancy category C substance. This means that animal reproduction studies have shown an adverse effect on the foetus, but the benefits of the drug may still warrant its use in pregnant women despite the potential risks.
In one study, a 29-year-old pregnant woman with hypoparathyroidism was treated with calcitriol and calcium. The woman gave birth to a healthy girl, and her serum calcium levels were stabilised. However, the calcitriol dose had to be increased during the 33rd week of pregnancy to maintain normocalcaemia. In another study, eight out of ten pregnancies treated with calcitriol did not exhibit any adverse effects, and healthy babies were delivered. However, two cases reported serious adverse events, including premature closure of the frontal fontanelle and a stillbirth due to complex fetal malformation.
While the causative role of calcitriol administration in these adverse events is questionable, it is recommended that the use of calcitriol during pregnancy should be carefully monitored and controlled. The 1,25(OH)2D3 concentrations should be adapted to the physiological needs of the pregnancy, and serum calcium levels should be kept within the lower normal range.
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Calcitriol is not recommended during breastfeeding
Calcitriol is a prescription medication used to treat low levels of calcium in the blood of patients whose kidneys or parathyroid glands are not functioning well. It is also used to treat plaque psoriasis. It is a synthetic (man-made) active form of vitamin D3 (cholecalciferol).
The need for vitamin D and calcium to treat hypoparathyroidism is very low during breastfeeding. An excess of vitamin D administration can cause toxic symptoms such as hypercalcemia, hyperphosphatemia, cardiovascular damage, fatigue, headaches, nausea, and vomiting. Therefore, it is necessary to reduce vitamin D and calcium intake during breastfeeding to avoid causing hypercalcemia in the mother and infant.
In addition, calcitriol is known to have adverse effects on pregnant women and their unborn children. Animal studies have shown that high doses of calcitriol (about 6 times the maximum human dose) caused maternal mortality, decreased fetal weight, reduced newborn survival, and hypercalcemia in the offspring. There are no controlled data in human pregnancy, but the potential risks to the fetus are significant.
Therefore, it is recommended that breastfeeding be discontinued while taking calcitriol, or that the use of calcitriol be discontinued during breastfeeding. The decision should be made in consultation with a healthcare provider, taking into account the importance of the drug to the mother.
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Frequently asked questions
There are no well-controlled studies of calcitriol treatment in pregnant women. Animal studies have shown evidence of an increased occurrence of fetal damage, but the significance of this for humans is uncertain. The FDA categorises the drug as 'C', meaning that the potential benefits to the mother may outweigh the potential risks to the unborn child.
Animal studies have shown that high doses of calcitriol (6 times the maximum human dose) caused maternal mortality, decreased foetal weight, reduced newborn survival, and hypercalcemia in the offspring.
Tell your doctor immediately. It is not recommended to start taking this medication during pregnancy unless the benefit outweighs the risk to the foetus.
It is not recommended to take calcitriol while breastfeeding. It is presumed that the drug passes into breast milk and can cause serious adverse reactions in nursing infants.