Ergocalciferol (Ergocalciferol) - Summary

ERGOCALCIFEROL SUMMARY

ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration.
Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D₂ is found in plants and yeast and has no antirachitic activity.
There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity.
One USP Unit of vitamin D₂ is equivalent to one International Unit (IU), and 1 mcg of vitamin D₂ is equal to 40 IU.
Each softgel, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil.

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

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NEWS HIGHLIGHTS

Published Studies Related to Ergocalciferol

Paricalcitol Versus Ergocalciferol for Secondary Hyperparathyroidism in CKD Stages 3 and 4: A Randomized Controlled Trial. [2011.08.30]
BACKGROUND: The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear... CONCLUSIONS: Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT. Published by Elsevier Inc.

Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. [2011.04]
CONTEXT: Whether ergocalciferol (D(2)) and cholecalciferol (D(3)) are equally effective to increase and maintain serum 25-hydroxyvitamin D [25(OH)D] concentration is controversial. OBJECTIVE: The aim of the study was to evaluate the effect of daily and once monthly dosing of D(2) or D(3) on circulating 25(OH)D and serum and urinary calcium... CONCLUSIONS: Overall, D(3) is slightly, but significantly, more effective than D(2) to increase serum 25(OH)D. One year of D(2) or D(3) dosing (1,600 IU daily or 50,000 IU monthly) does not produce toxicity, and 25(OH)D levels of less than 30 ng/ml persist in approximately 20% of individuals. Substantial between-individual response to administered vitamin D(2) or D(3) is observed.

Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. [2011]
calcium... CONCLUSIONS: Overall, D(3) is slightly, but significantly, more effective than

Treatment and prevention of vitamin D insufficiency in cystic fibrosis patients: comparative efficacy of ergocalciferol, cholecalciferol, and UV light. [2009.06]
BACKGROUND: The optimal treatment for correcting or preventing vitamin D insufficiency in cystic fibrosis (CF) patients has not been established. OBJECTIVE: The aim of the study was to assess the relative efficacy of three modes of vitamin D therapy: cholecalciferol (D3), ergocalciferol (D2), and UV light in raising or maintaining 25(OH)D levels above 30 ng/ml... CONCLUSION: This study demonstrates that CF subjects are able to achieve or maintain optimal vitamin D status (>30 ng/ml) with two oral regimens of either D3 or D2 treatment, the former being more efficacious. A confounding variable for this observation is the fact that the D3 and D2 capsules contained different carriers, powder-based vs. oil-based, respectively. UV therapy did not alter vitamin D status, possibly due to poor adherence to UV therapy.

Effects of ergocalciferol added to calcium on the risk of falls in elderly high-risk women. [2008.01.14]
BACKGROUND: Ergocalciferol (vitamin D(2)) supplementation plays a role in fall prevention, but the effect in patients living in the community in sunny climates remains uncertain. We evaluated the effect of ergocalciferol and calcium citrate supplementation compared with calcium alone on the risk of falls in older women at high risk of falling... CONCLUSION: Patients with a history of falling and vitamin D insufficiency living in sunny climates benefit from ergocalciferol supplementation in addition to calcium, which is associated with a 19% reduction in the relative risk of falling, mostly in winter.

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Clinical Trials Related to Ergocalciferol

Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy [Active, not recruiting]
Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.

Vitamin D Levels and Vitamin D Education in Geriatric Patients [Completed]
Vitamin D is important to maintain good health. Although it is found in foods and vitamins, many people still have low vitamin D levels. One purpose of this study is to describe vitamin D levels from patients at the University of Colorado Seniors Clinic. Another goal of the study is to find out if education by a pharmacist can increase vitamin D levels in patients who have low vitamin D levels.

Vitamin D Deficiency, Insulin Resistance and FGF-23 [Completed]
The purpose of this project is to determine if treating vitamin D deficiency decreases insulin resistance and improves insulin secretion in healthy volunteers. Additionally, this project will investigate if treating vitamin D deficiency affects a new phosphate-regulating hormone called FGF-23.

Randomized Study of Exercise and Vitamin D in Frail Elderly Subjects. [Terminated]
The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.

Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity [Active, not recruiting]
Obese persons are known to have elevated levels of parathyroid hormone (PTH) and low levels of vitamin D. These hormones are important in regulation of the body’s calcium stores and bone health. We would like to investigate these abnormalities and the accuracy of our current diagnostic tests by comparing results of standard assays for vitamin D and PTH to more specific tests, in obese subjects at baseline and as vitamin D is replaced. We will also compare two standard vitamin D replacement regimens to determine if one is more effective.

This is a pilot study with two parts: Part 1 will compare levels of PTH and vitamin D using two different assays in obese subjects who have normal vitamin D and those who do not. We plan to enroll 20 subjects who have normal vitamin D levels and 40 subjects who have vitamin D insufficiency. All subjects will fill out questionnaires about the amount of calcium and vitamin D in their diet, and their recent sunlight exposure. We will ask for blood samples so that we can measure levels of calcium, vitamin D, albumin, creatinine, glucose, insulin and the different forms of PTH.

Subjects who have vitamin D insufficiency will then be randomized to receive Vitamin D2 or Vitamin D3 in standard doses for eight weeks, in an open label trial. At four and eight weeks, these subjects will fill out the above questionnaires and have the blood tests repeated. For safety purposes, urine calcium will also be monitored.

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Reports of Suspected Ergocalciferol Side Effects

Pancreatitis Acute (4),  Oedematous Pancreatitis (4),  Drug Hypersensitivity (3),  Pruritus (2),  Rhabdomyolysis (2),  Pyrexia (2),  Iron Deficiency Anaemia (2),  Erosive Duodenitis (2),  Tearfulness (2),  Stevens-Johnson Syndrome (2), more >>