Improving Multivitamin Supplementation to Pregnant Women

The Hospital for Sick Children

Status and phase: Completed; Phase 4

Conditions: Vomiting; Nausea; Hyperemesis Gravidarum; Morning Sickness; Pregnancy

Treatments: Drug: Orifer F®; Drug: Pregvit®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02300155

1000005135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,370 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,370 participants in 2 patient groups

PregVit®

Experimental group

Description:

Women will be randomized to the '35 mg' group, who will start supplementation with PregVit® (low iron content, small size)

Treatment:

Drug: Pregvit®

Orifer F®

Active Comparator group

Description:

Women will be randomized to the '60 mg' group, who will start supplementation with Orifer F® (high iron content, small size).

Treatment:

Drug: Orifer F®

Sponsors of this trial

Lead Sponsor

The Hospital for Sick Children

Collaborating Sponsor

Duchesnay