Clinical trial NCT02300155: Improving Multivitamin Supplementation to Pregnant Women
Official title: Improving Multivitamin Supplementation to Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Morning Sickness
Nausea
Vomiting
Hyperemesis Gravidarum
Keywords: Pregnancy
Morning Sickness
nausea and vomiting
hyperemesis gravidarum
perinatal vitamins
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Duchesnay Inc.
First posted: 2014-11-24
Enrollment: 1370
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Any woman who discontinued her standard vitamins due to gastrointestinal symptoms or due to the tablet size, with one ofthe following conditions:

* Morning sickness.
* Gastrointestinal disorders: Crohn's disease, ulcerative colitis, peptic or duodenal ulcer, irritable colon, celiac disease.
* Iron deficiency anemia.
* Hypothyroidism.
* Depression.

Exclusion Criteria:

* Women who do not agree to consent to this protocol.
* Women with a known hypersensitivity to any of the ingredients of Pregvit®, or Orifer® F.

Primary outcomes:
measure: The difference in rates of ability to take multivitamin [either Pregvit® or Orifer®F]
timeFrame: Study completion was defined as completing monthly telephone interviews (when possible) to document pill intake and adverse events up until the end of pregnancy (i.e. 36 weeks gestation or further).
Secondary outcomes:
measure: The overall use of Pregvit® vs Orifer®F (adherence)
timeFrame: Study completion was defined as completing monthly telephone interviews (when possible) to document pill intake and adverse events up until the end of pregnancy (i.e. 36 weeks gestation or further).
measure: The rates of overall adverse events and specific side effects between the two groups
timeFrame: Study completion was defined as completing monthly telephone interviews (when possible) to document pill intake and adverse events up until the end of pregnancy (i.e. 36 weeks gestation or further).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Gideon Koren, MD
role: PRINCIPAL_INVESTIGATOR
References: