A randomized trial investigating an iron-rich natural mineral water as a prophylaxis against iron deficiency in pregnancy.
Spatone Iron-Plus is a naturally occurring mineral water from Trefriw Wells Spa in Conwy County, North Wales, UK. It contains approximately 0.20 mg of iron per millilitre as ferrous sulphate and has been shown to provide iron in a highly bio-available form. A 24 ml sachet contains approximately 5 mg of iron. Iron deficiency is common in the obstetric population. However, compliance with traditional iron supplements is poor because of gastrointestinal side-effects. We designed a randomized, double-blind, placebo-controlled trial. A total of 102 low-risk antenatal patients, who were noncompliant with routinely prescribed ferrous sulphate tablets, were randomized to receive 48 ml of Spatone water or placebo. The study was conducted between 22 and 28 weeks gestation. Primary outcome measures were compliance, gastrointestinal side-effects and changes in ferritin levels during the trial period. Compliance in the intervention group was 57% compared with 67% in the control group, P = 0.22. Dyspepsia scores, as determined by a recognized and well-validated questionnaire, did not differ between the two groups. During the trial period, mean ferritin levels fell by 24% in the Spatone Iron-Plus group compared with a mean fall of 51% in ferritin levels among the control group, P = 0.016.
McKenna
D
D
Royal Victoria Hospital, Belfast, Northern Ireland, UK. dan.mckenna@virgin.net
Spence
D
D
Haggan
S E
SE
McCrum
E
E
Dornan
J C
JC
Lappin
T R
TR
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced / Q000175:diagnosis; D005260:Female; D005293:Ferritins / Q000032:analysis / Q000097:blood / Q000187:drug effects; D005296:Ferrous Compounds / Q000494:pharmacology; D006454:Hemoglobins / Q000032:analysis / Q000187:drug effects; D006801:Humans; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects; D000090463:Iron Deficiencies; D008900:Mineral Waters / Q000008:administration & dosage*; D010349:Patient Compliance; D018579:Patient Selection; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood / Q000517:prevention & control*; D017701:Reticulocyte Count; D013223:Statistics as Topic; D013997:Time Factors; D016896:Treatment Outcome
D005296:Ferrous Compounds; D006454:Hemoglobins; D008900:Mineral Waters; D005293:Ferritins; D007501:Iron