A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation

Abstract

BackgroundOral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.MethodsThe study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n = 10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).ResultsSeventy five per cent of participants reporting the presence of one or more symptoms in the first week of the study were in the ferrous sulphate group. In the second week of the study (i.e. wash-out), 67% of the participants reporting one or more symptom(s) were in the ferrous sulphate group. In the first week of the study (treatment) the number of symptoms reported by participants in the ferrous sulphate group (mean ± SEM = 6.7 ± 1.7) was significantly higher than that for participants in the placebo group (1.2 ± 0.5) (p = 0.01). In the second week of the study (wash-out) the number of symptoms reported by participants in the ferrous sulphate group (4.6 ± 2.0) appeared higher than for participants in the placebo group (1.0 ± 0.7) although this did not reach significance (p = 0.12). Events for which the gastrointestinal symptom questionnaire was most discriminatory between ferrous sulphate and placebo groups were: heartburn, abdominal pain and the presence of black stools (all p ≤ 0.03).ConclusionsA tool for the detection of commonly-occurring side effects should not require large study numbers to be effective. With just 10 subjects per group (iron or placebo), this simple questionnaire measures gastrointestinal side-effects associated with oral iron (ferrous sulphate) supplementation, and would be appropriate for use in intervention studies or clinical trials.Trial registrationClinicalTrials.gov Identifier: NCT02146053 (21/05/2014).

Novel Iron-Whey Protein Microspheres Protect Gut Epithelial Cells from Iron-Related Oxidative Stress and Damage and Improve Iron Absorption in Fasting Adults

“…However, oral iron remains poorly absorbed despite decades of food fortification and supplementation, and has resulted in the widespread use of poorly tolerated, high-dose formulations [3,4,11,12,14]. This is the first clinical report of iron absorption from Iron-WP microspheres.…”

“…Ferrous sulphate (FeSO 4 ) continues to be the only oral iron recommended by the World Health Organisation (WHO) Essential Medicines List [13]. It is inexpensive and has better absorption relative to other inorganic ferrous and ferric salts, but is also poorly tolerated [11,12,14,15]. Modified-release formulations as well as novel iron salts have been developed to overcome iron intolerance [16,17,18].…”

Relationships among Dietary Intakes and Persistent Gastrointestinal Symptoms in Patients Receiving Enzyme Treatment for Genetic Sucrase-Isomaltase Deficiency

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Development and validation of a questionnaire for measuring drug-induced nausea

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