Improving Multivitamin Supplementation to Pregnant Women
Condition: Pregnancy; Morning Sickness; Nausea; Vomiting; Hyperemesis Gravidarum
MeSH terms: Hyperemesis Gravidarum; Morning Sickness; Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the tolerability of Pregvit® to a common prenatal
      vitamin (Orifer® F) among pregnant women with morning sickness or those suffering from a
      variety of conditions.
    

Detailed description: 
      Presently, there is a large choice of perinatal vitamins on the market. Materna® is taken by
      70% of Canadian women. A recent study by the investigators team has shown that up to 35%-53%
      of women with moderate to severe morning sickness discontinue their Materna®. One main reason
      is that its large size causes difficulties in swallowing, which prompts women to stop taking
      the drug. The second main reason for stopping is gastrointestinal adverse effects from the
      iron content, which causes nausea, vomiting and constipation.

      A new periconceptional multivitamin supplement, Pregvit®, was introduced to the market in
      September 2003 by the Canadian company Duchesnay Inc. with the aim of trying to overcome the
      disadvantages of the existing multivitamin supplements. PregVit® is a prenatal multivitamin
      that contains 35 mg elemental iron, as ferrous fumarate. It is formulated into 2 small
      tablets (each tablet:16 mm × 9 mm × 4 mm), containing different vitamins and minerals,
      particularly separating the iron (morning tablet) from the calcium (evening tablet) to
      optimize iron absorption. The use of PregVit® requires a physician's prescription.

      Since Materna® or other generic products are the most commonly used non-prescription (i.e.
      over-the-counter) prenatal multivitamins, they were not selected for comparison in the study
      because enrolled subjects who had discontinued a prenatal multivitamin most likely had
      discontinued any one of them. Ethically, subjects in this situation cannot be randomized to
      resume Materna® or another generic prenatal multivitamin.

      Instead, Orifer F® was selected as the small-tablet prenatal multivitamin (one tablet: 5 mm
      radius, 5 mm thickness), containing a high iron content (60 mg elemental iron as ferrous
      sulphate). It is taken daily as a single tablet and the use of Orifer F® does not require a
      physician prescription (i.e. over-the-counter).

      Comparing tolerability of PregVit® to Orifer F® would address separation of the potential
      effect of iron content from that of tablet size on multivitamin tolerability among pregnant
      women and women suffering from morning sickness or those suffering from a variety of
      conditions such as, Crohn's Disease, Ulcerative Colitis, Peptic-Duodenal Ulcer, Irritable
      Bowel Syndrome, Celiac Disease, as well as anemia or hypothyroidism.
    

Intervention name(s): Pregvit®; Orifer F®
Intervention type(s): Drug; Drug
Intervention description(s): Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing -twice daily for '35 mg' group; Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing-once daily for '60 mg' group
Other intervention name(s): Dietary supplement-prenatal multivitamin; Dietary supplement-prenatal multivitamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy; Morning Sickness; nausea and vomiting; hyperemesis gravidarum; perinatal vitamins