Ergocalciferol
Regulatory sources consulted
Approved indications
- Treatment of hypoparathyroidism, vitamin-D-resistant rickets, and familial hypophosphataemia.
Contraindications
Absolute
- Hypercalcaemia.
- Malabsorption syndrome.
- Abnormal sensitivity to the toxic effects of vitamin D.
- Hypervitaminosis D.
Clinical warnings
- Major warning · The margin between therapeutic and toxic doses is narrow in vitamin-D-resistant rickets. Individualise dosing and monitor serum calcium frequently to prevent hypercalcaemia and metastatic calcification. — DailyMed ergocalciferol setid 75fa8580-3322-473d-b836-4929f8c40165
- Major warning · Manifestations of hypervitaminosis D may include nausea, anorexia, constipation, weakness, non-specific aches and stiffness. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75fa8580-3322-473d-b836-4929f8c40165
Drug interactions
- ModerateMineral oil
Mechanism: Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D.
Recommendation: Avoid simultaneous administration or separate doses and monitor clinical response.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75fa8580-3322-473d-b836-4929f8c40165DailyMed setid 75fa8580-3322-473d-b836-4929f8c40165
- ModerateThiazide diuretics
Mechanism: In patients with hypoparathyroidism, the combination may cause hypercalcaemia.
Recommendation: Monitor serum calcium and adjust treatment if hypercalcaemia occurs.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75fa8580-3322-473d-b836-4929f8c40165DailyMed setid 75fa8580-3322-473d-b836-4929f8c40165
Adverse events
Rare but serious
Renal failure, nephrocalcinosis, or azotaemia · Vascular and soft-tissue calcification · Bone demineralisation · Neurological effects of hypervitaminosis D · Severe hypercalcaemia
Pregnancy and lactation
FDA category: C
During a normal pregnancy, avoid exceeding the recommended daily allowance unless the potential benefit justifies the risk; safety above 400 IU of vitamin D daily has not been established. Use cautiously while breastfeeding; with high doses, monitor the infant's serum calcium.
Recent literature (PubMed)
Numerous studies demonstrate associations between serum concentrations of 25-hydroxyvitamin D (25[OH]D) and a variety of common disorders, including musculoskeletal, metabolic, cardiovascular, malignant, autoimmune, and infectious diseases. Although a causal link between serum 25(OH)D concentrations and many disorders has not been clearly established, these associations have led to widespread supplementation with vitamin D and increased laboratory testing for 25(OH)D in the general population. The benefit-risk ratio of this increase in vitamin D use is not clear, and the optimal vitamin D intake and the role of testing for 25(OH)D for disease prevention remain uncertain. To develop clinical guidelines for the use of vitamin D (cholecalciferol [vitamin D3] or ergocalciferol [vitamin D2]) to lower the risk of disease in individuals without established indications for vitamin D treatment or 25(OH)D testing. A multidisciplinary panel of clinical experts, along with experts in guideline methodology and systematic literature review, identified and prioritized 14 clinically relevant questions related to the use of vitamin D and 25(OH)D testing to lower the risk of disease. The panel prioritized randomized placebo-controlled trials in general populations (without an established indication for vitamin D treatment or 25[OH]D testing), evaluating the effects of empiric vitamin D administration throughout the lifespan, as well as in select conditions (pregnancy and prediabetes). The panel defined "empiric supplementation" as vitamin D intake that (a) exceeds the Dietary Reference Intakes (DRI) and (b) is implemented without testing for 25(OH)D. Systematic reviews queried electronic databases for publications related to these 14 clinical questions. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and guide recommendations. The approach incorporated perspectives from a patient representative a
Both vitamin D insufficiency and deficiency are now well-documented worldwide in relation to human health, and this has raised interest in vitamin D research. The aim of this article is therefore to review the literature on sources of vitamin D. It can be endogenously synthesised under ultraviolet B radiation in the skin, or ingested through dietary supplements and dietary sources, which include food of animal and plant origin, as well as fortified foods. Vitamin D is mainly found in two forms, D3 (cholecalciferol) and D2 (ergocalciferol). In addition to the D3 and D2 forms of vitamin D, 25-hydroxy vitamin D also contributes significantly to dietary vitamin D intake. It is found in many animal-derived products. Fortified food can contain D3 or D2 forms or vitamin D metabolite 25-hydroxy vitamin D. Not many foods are a rich source (> 4 μg/100 g) of vitamin D (D represents D3 and/or D2), e.g., many but not all fish (5-25 μg/100 g), mushrooms (21.1-58.7 μg/100 g), Reindeer lichen (87 μg/100 g) and fish liver oils (250 μg/100 g). Other dietary sources are cheese, beef liver and eggs (1.3-2.9 μg/100 g), dark chocolate (4 μg/100 g), as well as fortified foods (milk, yoghurt, fat spreads, orange juice, breakfast grains, plant-based beverages). Since an adequate intake of vitamin D (15 μg/day set by the European Food Safety Authority) is hard to achieve through diet alone, dietary supplements of vitamin D are usually recommended. This review summarizes current knowledge about different sources of vitamin D for humans. Vitamin D is a normal component of human milk. Daily maternal vitamin D2 or D3 supplementation in the 10 to 50 mcg (400 to 2,000 IU) range produces milk concentrations that are inadequate to deliver the daily requirement to an exclusively breastfed infant, and inadequate to correct pre-existing infant vitamin D deficiency through breastfeeding alone. Breastfeeding mothers who take vitamin D supplements in this range should give their infants a daily vitamin D
Type 1 diabetes mellitus (T1DM) is a multifactorial disease in which environmental factors and genetic predisposition interact to induce an autoimmune response against pancreatic β-cells. Vitamin D promotes immune tolerance through immunomodulatory and anti-inflammatory functions. The aim of this study is to provide a narrative review about the association between vitamin D status in the pathogenesis of T1DM and the role of vitamin D supplementation in the prevention and treatment of T1DM. Although vitamin D deficiency is more prevalent in children/adolescents with new-onset T1DM than in healthy individuals, there does not appear to be an association between vitamin D status before diagnosis and the onset of T1DMD later in life. The results of vitamin D as adjuvant therapy have, at best, a positive short-term effect in newly diagnosed T1DM patients. Intervention studies have been conducted in the clinical phase of T1DM, but it would be desirable to do so in the early stages of the autoimmune process (pre-diabetes).
Vitamin D is important for musculoskeletal health. Concentrations of 25-hydroxyvitamin D, the most commonly measured metabolite, vary markedly around the world and are influenced by many factors including sun exposure, skin pigmentation, covering, season and supplement use. Whilst overt vitamin D deficiency with biochemical consequences presents an increased risk of severe sequelae such as rickets, osteomalacia or cardiomyopathy and usually warrants prompt replacement treatment, the role of vitamin D supplementation in the population presents a different set of considerations. Here the issue is to keep, on average, the population at a level whereby the risk of adverse health outcomes in the population is minimised. This position paper, which complements recently published work from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, addresses key considerations regarding vitamin D assessment and intervention from the population perspective. This position paper, on behalf of the International Osteoporosis Foundation Vitamin D Working Group, summarises the burden and possible amelioration of vitamin D deficiency in global populations. It addresses key issues including screening, supplementation and food fortification.