Delivery Vehicles for Prenatal Calcium Supplementation

Pregnancy Clinical Trial

Official title:

Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676636
• Other study ID #: 1000032744
• Status: Completed
• Start date: October 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The SickKids-led research team is currently developing a prenatal micronutrient powder that will contain calcium, iron, and folic acid with different absorption characteristics. Once the powder is developed, it can be incorporated into various oral delivery vehicles. The overall effectiveness of a micronutrient program is highly dependent on the acceptance and regular consumption of supplements (i.e., adherence) by the targeted users. This is a study of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the innovative prenatal multiple micronutrient supplement: traditional tablets, oral disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study hypothesizes that that the formulation of the delivery vehicle will impact preference, acceptability, and palatability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women ages 18 to < 40 years

• 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:

• Reported complications of current pregnancy

• 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)

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bangladesh	International Center for Diarrheal Disease Research	Dhaka
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	International Centre for Diarrhoeal Disease Research, Bangladesh, The Sprinkles Global Health Initiative

Countries where clinical trial is conducted

Bangladesh,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Consumption of the Calcium Vehicle	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.	Change from Baseline in Consumption of the Calcium Vehicle at day 22
Secondary	Acceptability	Measured by colour, preparation, administration.	Day 1, Day 9, Day 16, Day 22
Secondary	Ease of Use	Measured by size and ease of swallowing.	Day 1, Day 9, Day 16, Day 22
Secondary	Patibility	Measured by taste, texture, aftertaste, and odour.	Day 1, Day 9, Day 16, Day 22