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      A randomized cross over trial of tolerability and compliance of a micronutrient supplement with low iron separated from calcium vs high iron combined with calcium in pregnant women [ISRCTN56071145]

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          Abstract

          Background

          Prenatal micronutrient combinations with high iron content are associated with high rates of gastrointestinal symptoms. This coupled with nausea and vomiting of pregnancy results in women often discontinuing their multivitamins.

          A new prescription supplement (PregVit ®) that separates iron from calcium in two tablets – morning and evening, has lower elemental iron content (35 mg), but results in similar extent of iron absorption when compared to another supplement containing (60 mg) of elemental iron (Materna ®). The objectives of this study were to compare tolerability and compliance with PregVit ® vs. a supplement with high iron content (Materna ®), in pregnant women.

          Methods

          Randomized, crossover open labeled study in 135 pregnant women attending outpatient clinics in Ontario and Quebec.

          Results

          Use of PregVit ® was associated with a 30% reduction in constipation rate as compared to Materna ®. Both products demonstrated similar compliance rates.

          Compliance of Materna ® was negatively associated with the severity of nausea and vomiting of pregnancy. No such correlation was found for PregVvit ®.

          Conclusion

          PregVit ®, a supplement with lower iron content (35 mg), has significantly decreased constipation rates as compared to 60 mg iron- Materna and has similar compliance rates. High iron content in multivitamin supplements is associated with adverse effects in pregnancy.

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          Most cited references21

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          Iron requirements in pregnancy and strategies to meet them.

          T BOTHWELL (2000)
          Iron requirements are greater in pregnancy than in the nonpregnant state. Although iron requirements are reduced in the first trimester because of the absence of menstruation, they rise steadily thereafter; the total requirement of a 55-kg woman is approximately 1000 mg. Translated into daily needs, the requirement is approximately 0.8 mg Fe in the first trimester, between 4 and 5 mg in the second trimester, and >6 mg in the third trimester. Absorptive behavior changes accordingly: a reduction in iron absorption in the first trimester is followed by a progressive rise in absorption throughout the remainder of pregnancy. The amounts that can be absorbed from even an optimal diet, however, are less than the iron requirements in later pregnancy and a woman must enter pregnancy with iron stores of >/=300 mg if she is to meet her requirements fully. This is more than most women possess, especially in developing countries. Results of controlled studies indicate that the deficit can be met by supplementation, but inadequacies in health care delivery systems have limited the effectiveness of larger-scale interventions. Attempts to improve compliance include the use of a supplement of ferrous sulfate in a hydrocolloid matrix (gastric delivery system, or GDS) and the use of intermittent supplementation. Another approach is intermittent, preventive supplementation aimed at improving the iron status of all women of childbearing age. Like all supplementation strategies, however, this approach has the drawback of depending on delivery systems and good compliance. On a long-term basis, iron fortification offers the most cost-effective option for the future.
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            Effect of tea and other dietary factors on iron absorption.

            L Tijburg, O Korver, Nienke Zijp (2000)
            Iron deficiency is a major world health problem, that is, to a great extent, caused by poor iron absorption from the diet. Several dietary factors can influence this absorption. Absorption enhancing factors are ascorbic acid and meat, fish and poultry; inhibiting factors are plant components in vegetables, tea and coffee (e.g., polyphenols, phytates), and calcium. After identifying these factors their individual impact on iron absorption is described. Specific attention was paid to the effects of tea on iron absorption. We propose a calculation model that predicts iron absorption from a meal. Using this model we calculated the iron absorption from daily menus with varying amounts of enhancers and inhibitors. From these calculations we conclude that the presence of sufficient amounts of iron absorption enhancers (ascorbic acid, meat, fish, poultry, as present in most industrialized countries) overcomes inhibition of iron absorption from even large amounts of tea. In individuals with low intakes of heme iron, low intakes of enhancing factors and/or high intakes of inhibitors, iron absorption may be an issue. Depletion of iron stores enhances iron absorption, but this effect is not adequate to compensate for the inhibition of iron absorption in such an inadequate dietary situation. For subjects at risk of iron deficiency, the following recommendations are made. Increase heme-iron intake (this form of dietary iron present in meat fish and poultry is hardly influenced by other dietary factors with respect to its absorption); increase meal-time ascorbic acid intake; fortify foods with iron. Recommendations with respect to tea consumption (when in a critical group) include: consume tea between meals instead of during the meal; simultaneously consume ascorbic acid and/or meat, fish and poultry.
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              Competitive inhibition of iron absorption by manganese and zinc in humans.

              L Rossander, M Brüne, B. Lönnerdal … (1991)
              Zinc and manganese may interfere with iron absorption because of similar physicochemical properties and shared absorptive pathways. The effects of zinc and manganese on iron absorption were studied in human subjects by using paired observations and a dual-radioisotope method (55Fe and 49Fe). Manganese inhibited iron absorption both in solutions and in a hamburger meal. Fractional iron absorption is strongly dose dependent. Adding 2.99 mg Mn to 0.01 mg Fe reduced iron absorption to the same extent as increasing the iron dose 300-fold to 3 mg, strongly indicating a direct competitive inhibition of manganese on iron absorption. In the same experiment with zinc, no inhibitory effect was observed, suggesting different pathways for the absorption of zinc and iron. An intraluminal interaction may occur, because a fivefold excess of zinc to iron (15 mgZn/3 mg Fe) reduced iron absorption by 56% when given in a water solution but not when given with a hamburger meal.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMC Pregnancy Childbirth
                Title: BMC Pregnancy and Childbirth
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2393
                Publication date Collection: 2006
                Publication date (Electronic): 4 April 2006
                Volume: 6
                Page: 10
                Affiliations
                [1 ]The University of Toronto, Clinique de Gynécologie-Obstétrique Pierre Boucher, Longueuil, Québec, Canada
                [2 ]Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, North York General Hospital, Toronto, Canada
                Article
                Publisher ID: 1471-2393-6-10
                DOI: 10.1186/1471-2393-6-10
                PMC ID: 1481554
                PubMed ID: 16595003
                SO-VID: b0e300cd-6687-4cc3-beb1-0f004addfd76
                Copyright © Copyright © 2006 Ahn et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 17 October 2005
                Date accepted : 4 April 2006
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Obstetrics & Gynecology
                Data availability:
                ScienceOpen disciplines: Obstetrics & Gynecology

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