Delivery Vehicles for Prenatal Calcium Supplementation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01676636|
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : April 15, 2013
|Condition or disease||Intervention/treatment|
|Pregnancy||Drug: Traditional Tablet Drug: Chewable tablets Drug: Unflavoured Powder Drug: Flavoured Powder|
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Official Title:||Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.
Drug: Traditional Tablet
The traditional tablets will be swallowed with liquid. Each tablet will contain 500 mg of calcium (as calcium carbonate), thus participants will be asked to take 3 per day.. Participants will be asked to take the tablets with a liquid of their choosing with a meal. Traditional tablets will function as a control in this study, as they represent what is widely available on the market in Bangladesh.
Drug: Chewable tablets
Chewable tablets are chewed in the absence of additional water. Each chewable tablet will contain 300 mg of calcium (as calcium carbonate), thus participants will be asked to take 5 per day. Participants will be asked to consume the chewable tablets with a meal.
Drug: Unflavoured Powder
The unflavoured powder with suspension agent will be tasteless and consumed by either adding it to a semi-solid food or drink of one's choosing. Appropriate foods for mixing with the powder will be at the discretion of the participants. This vehicle was selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. A similar product is Sprinkles, a multiple micronutrient powder developed at SickKids by Dr. Zlotkin.
Drug: Flavoured Powder
The flavoured powder with suspension agent will be consumed by adding it to clean water with a meal. This vehicle was also selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. Similar products include oral rehydration salts or artificial juice flavour crystals.
- Frequency of Consumption of the Calcium Vehicle [ Time Frame: Change from Baseline in Consumption of the Calcium Vehicle at day 22 ]Consumption of the delivery vehicles will be measured during the once-weekly interactions with the research assistants in two ways: (1) by self-report from study participants; and (2) by counting the number of missing doses from those provided in the weekly supply.
- Acceptability [ Time Frame: Day 1, Day 9, Day 16, Day 22 ]Measured by colour, preparation, administration.
- Ease of Use [ Time Frame: Day 1, Day 9, Day 16, Day 22 ]Measured by size and ease of swallowing.
- Patibility [ Time Frame: Day 1, Day 9, Day 16, Day 22 ]Measured by taste, texture, aftertaste, and odour.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676636
|International Center for Diarrheal Disease Research|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Stanley Zlotkin, MD||The Hospital for Sick Children|
|Principal Investigator:||Daniel Roth, MD||The Hospital for Sick Children|