Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
149 participants
OBSERVATIONAL
2012-10-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Women
Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Gestational age of 13-30 completed weeks, estimated based on the recalled first day of the last menstrual period (LMP)
* Current residence in Dhaka at a fixed address
* Plan to remain in Dhaka for the duration of the study
Exclusion Criteria
* Complicated medical or obstetric history that may increase the risk of preterm birth or prenatal complications, based on self-report
* Moderate or severe anaemia (hemoglobin \< 90 g/L, accessed with Hemocue)
18 Years
40 Years
FEMALE
Yes
Sponsors
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The Sprinkles Global Health Initiative
UNKNOWN
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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Stanley Zlotkin
Chief, Global Child Health
Principal Investigators
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Stanley Zlotkin, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Daniel Roth, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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International Center for Diarrheal Disease Research
Dhaka, , Bangladesh
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Baxter JA, Roth DE, Al Mahmud A, Ahmed T, Islam M, Zlotkin SH. Tablets are preferred and more acceptable than powdered prenatal calcium supplements among pregnant women in Dhaka, Bangladesh. J Nutr. 2014 Jul;144(7):1106-12. doi: 10.3945/jn.113.188524. Epub 2014 Apr 23.
Other Identifiers
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1000032744
Identifier Type: -
Identifier Source: org_study_id
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