Pharmaceutical Name

Trade (marketing or proprietary) name: Vitamin D

Generic (nonproprietary or active ingredient) name: Ergocalciferol Capsules, USP

Indication and Usage

Reason the product has been approved for sale on the market.

Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Ergocalciferol, soybean oil, gelatin, glycerin, water, D&C yellow no. 10, FD&C Blue no. 1

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted.

Keep out of the reach of children.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Impairment of renal function with polyuria, Nocturia (waking at night to urinate), Polydipsia (feeling of extreme thirstiness), Hypercalciuria (elevated calcium in the urine), Reversible azotemia (abnormally high levels of nitrogen-containing compounds in the blood), Hypertension, Nephrocalcinosis, Anorexia, Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs, Bone demineralization (osteoporosis) in adults occurs concomitantly, Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism), Vague aches, Stiffness, Weakness, Nausea, Constipation, Mild acidosis, Anemia, Generalized vascular calcification, Irreversible renal insufficiency which may result in death, Mental retardation, and Weight loss.

Specific Populations

Pregnancy

Pregnancy Category C: Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP units of vitamin D daily during pregnancy has not been established.

Breastfeeding

Caution should be exercised when ergocalciferol is administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infant’s serum calcium concentration is required in that case (Goldberg, 1972).

Fertility

No long-term animal studies have been performed to evaluate the drug’s potential in these areas.

Pediatric

Pediatric doses must be individualized with provider.

Drug Interactions

Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations.

Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

The  in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorous by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.

There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.

Analytical Deep Dive

What is informed consent?

Alternatives

Looking for Ergocalciferol Capsules alternatives? Here are some products to research:

For natural Vitamin D, early exposure to the sun without sunscreen for 15-60 min daily can help improve levels. If that’s hard to attain for your personal situation, an organic/non-GMO Vitamin D supplement may help.

Perfect Supplements Perfect D3 Drops

$17.06 with discount | “JUSTTHEINSERTS” for 10% off.

Ask your Doctor do a blood test to check your Vitamin D levels (ask for a 25-vitamin D assay), but if you listen to your body, there are some clear signals that you are deficient in Vitamin D. If you have body aches, lethargy, thinning hair and nails, moodiness, or trouble sleeping – there is a good chance that you are deficient in Vitamin D.

Known as “The Sunshine Vitamin”, Perfect Supplements’ all natural Vitamin D3 provides 5,000 IU of the same biologically active form of Vitamin D produced by the body when exposed to sunlight, but without the risk of UVB exposure. Made with 5,000 IU of the cholecalciferol form of Vitamin D3 — the most absorbable and most effective form of Vitamin D.

Perfect Supplements x Garden of Life Vitamin Code Raw D3

$21.59 with discount | “JUSTTHEINSERTS” for 10% off.

Garden of Life’s RAW Vitamin D3 is a whole food vitamin D complex that is gluten- and dairy-free with no binders or fillers, and contains live probiotics and enzymes. Most importantly, Vitamin Code RAW D3 is a raw, naturally occurring, plant-based source of vitamin D3. Also comes in 5,000 IU (125 mcg)

Because magnesium is essential in Vitamin D absorption, here are a few magnesium products to research:

Rowe Casa Organics Magnesium Gel

$20 with discount | For your first Rowe Casa Organics order, use discount code “JUSTTHEINSERTS” for 20% off.

Rowe Casa Magnesium Gel combines magnesium oil with calming essential oils in a light gel base. This Magnesium Gel can promote sleep, relieve anxiety, and soothe aching muscles.

Magnesium is essential for over 300 biochemical reactions in our bodies. Magnesium deficiency can cause migraines, sleepless nights, fatigue, leg cramps, and muscle soreness. The most effective way to replenish magnesium without digestive issues is through skin absorption, so our specially formulated gel is the perfect solution!

Also available in a spray + cream.

Urban Farm Collection x Wild Foods Wild Magnesium Complex

$26.50

Magnesium is an essential mineral in over 300+ biochemical processes in the human body. When you are low in magnesium, your body is strained. It’s largely missing from our Western diet, due to depleted soils and an excess of calcium, which reduces magnesium absorption and retention when magnesium intake is already low. Magnesium regulates sleep, inflammation, digestion and stress in the body, and deficiency has been linked to many different chronic health issues. This complex contains SEVEN forms of bioavailable Magnesium, for maximum absorption.