Serum β-Carotene, Retinol, and α-Tocopherol Levels During Mineral Oil Therapy for Constipation

Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

“…non-stimulant) laxative. 21 Mineral oil treats constipation at doses of 15–45 mL, markedly higher than placebo doses. 5 , 22 As a lubricant laxative, mineral oil coats the bowel and stool mass with a waterproof film that retards water absorption, leading to retention of moisture in the stool.…”

“…74 Although a few have warned about the possibility of interference by mineral oil on absorption of drugs and nutrients, this appears to be based on theoretical concern rather than actual data, and the risk is likely clinically insignificant. 26 , 75 Mineral oil likely has no clinically significant impact on absorption of vitamins such as A, E, and K. 21 , 26 Studies have shown that fatty acids or vitamin D3 formulated in a nanoemulsion delivery system of indigestible mineral oil is less bioavailable than a similar emulsion of digestible corn oil. 76 , 77 The relevance of these findings to absorption of fat-soluble vitamins and drugs not formulated in a nanoemulsion is not clear, as a vitamin D intervention study using pure liquid paraffin as a placebo found no reduction in vitamin D levels in the placebo group.…”

An Emulsified Liquid Paraffin Formulation for Functional Constipation: Pharmacokinetics of Vitamins K1, D3, A, and E in a Rat Model

“…Previously, in 1939, Curtis and Balmer [37] showed decreases in serum values of carotene (vitamin A) after some weeks of use of liquid paraffin, but values in the range of carotene deficiency were not found. In a study of serial monitoring (up to 4 months) of serum beta-carotene, retinol (vitamin A1), and alpha-tocopherol (vitamin E) levels during mineral oil therapy in 25 children with chronic constipation in whom mineral oil was administered between meals, concentrations of serum levels of retinol and alpha-tocopherol remained unchanged [19]. More recently, Gal-Ezer and Shaoul [22] reported a case report in a 17year-old girl illustrating the safety of prolonged administration of mineral oil (5 months) in the treatment of constipation without impairment of fat-soluble vitamin absorption.…”

Pediatric Constipation Therapy Using Guidelines and Polyethylene Glycol 3350

“…The concerns that some clinicians may have with administering mineral oil long-term, and its potential for inducing fat-soluble vitamin deficiencies, were not borne out in a 4-month study of mineral oil administration to 25 children. 15 Mineral oil administered between meals did not reduce serum levels of retinol or α-tocopherol. Stimulant laxatives (senna, bisacodyl) are not recommended for maintenance therapy, but may be used acutely to prevent fecal impaction (evidence grade II-3) or for patients who are difficult to manage with the above therapies (evidence grade II-1).…”