Vitamin D Intoxication Due to an Erroneously Manufactured Dietary Supplement in Seven Children

Abstract

Pediatric cases of vitamin D intoxication (VDI) with dietary supplements have not been previously reported. We report on 7 children with VDI caused by consumption of a fish oil supplement containing an excessively high dose of vitamin D due to a manufacturing error. Seven children aged between 0.7 and 4.2 years were admitted with symptoms of hypercalcemia. Initial median (range) serum concentrations of calcium and 25-hydroxyvitamin D were 16.5 (13.4-18.8) mg/dL and 620 (340-962) ng/mL, respectively. Repeated questioning of the parents revealed use of a fish oil that was produced recently by a local manufacturer. Analysis of the fish oil by gas chromatography/mass spectrometry revealed that the vitamin D 3 content was ∼4000 times the labeled concentration. Estimated daily amounts of vitamin D 3 intake varied between 266 000 and 800 000 IU. Patients were successfully treated with intravenous hydration, furosemide, and pamidronate infusions. With treatment, serum calcium returned to the normal range within 3 days (range: 2-7 days). Serum 25-hydroxyvitamin D levels normalized within 2 to 3 months. Complications, including nephrocalcinosis, were not observed throughout the 1-year followup. In conclusion, errors in manufacturing of dietary supplements may be a cause of VDI in children. Physicians should be aware of this possibility in unexplained VDI cases and repeatedly question the families about dietary supplement use. To prevent the occurrence of such unintentional incidents, manufacturers must always monitor the levels of ingredients of their products and should be rigorously overseen by governmental regulatory agencies, as is done in the pharmaceutical industry. Pediatrics 2014;133:e240-e244 Vitamin D intoxication (VDI) is a rare condition today. Over the past 40 years, it has been usually described as a result of unintentional conditions, such as contamination of cooking oil, 1-3 overfortification of milk, 4,5 or adulteration of table sugar. 6 VDI associated with overthe-counter dietary supplements has been reported in adult patients. [7][8][9][10][11][12] However, to our knowledge, pediatric cases of VDI caused by dietary supplements have not been previously reported. We report here on 7 young children with VDI caused by the consumption of a fish oil supplement that contained an excessively high dose of vitamin D due to a manufacturing error. CASE HISTORIESA 2.5-year-old boy was admitted on September 24, 2011, with a history of fever, weakness, constipation, loss of appetite, nausea, and vomiting for 2 weeks. He was clinically dehydrated. His serum calcium and 25-hydroxyvitamin D (25[OH]D) levels were 13.4 mg/dL (normal range: 8.8-10.8 mg/dL) and 962 ng/mL (normal range: 30-80 ng/mL), respectively. His parents denied taking any drug or dietary supplement containing vitamin D.The second male infant, aged 13 months, was admitted 2 weeks later with a history of weakness, poor appetite, vomiting, weight loss, and constipation for 12 days. His physical examination was normal. His serum calcium and 25(OH)D l...

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“…Fortification of orange juice with vitamin D 2 or D 3 may increase mean serum 25(OH)D with 15–25 nmol/L, with regular consumption . Fortification of dietary supplements carries the risk of vitamin D intoxication, as was recently seen in young children receiving 4000 times as much vitamin D in a fish oil supplement, as was stated on the product …”

Histochemical examination of the effects of high-dose 1,25(OH)2D3 on bone remodeling in young growing rats

“…Rajakumar et al (2013) described a case study of an infant who had hypervitaminosis D caused by a dosing error in an overthe-counter vitamin D supplement. Cengiz et al reported seven children aged between 0.7 and 4.2 years were admitted with symptoms of hypercalcemia caused by the consumption of a fish oil supplement containing an excessively high dose of vitamin D caused by a manufacturing error (Kara et al 2014).…”

The medico‐legal aspects of prescribing vitamin D

“…Similarly, Kara et al . reported seven paediatric cases admitted with hypercalcaemia and vitamin D intoxication associated with an approximate 4000 times higher vitamin D content than stated within a fish oil supplement. Examples of toxicity associated with inaccurately manufactured and labelled vitamin D supplements is an international problem which is increasingly reported .…”