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Delivery Vehicles for Prenatal Calcium Supplementation

This study has been completed.
Sponsor:
Collaborators:
The Sprinkles Global Health Initiative
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01676636
First received: August 16, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy
 Drug: Traditional Tablet
Drug: Chewable tablets
Drug: Unflavoured Powder
Drug: Flavoured Powder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Frequency of Consumption of the Calcium Vehicle [ Time Frame: Change from Baseline in Consumption of the Calcium Vehicle at day 22 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Acceptability [ Time Frame: Day 1, Day 9, Day 16, Day 22 ] [ Designated as safety issue: No ]
    Measured by colour, preparation, administration.

  • Ease of Use [ Time Frame: Day 1, Day 9, Day 16, Day 22 ] [ Designated as safety issue: No ]
    Measured by size and ease of swallowing.

  • Patibility [ Time Frame: Day 1, Day 9, Day 16, Day 22 ] [ Designated as safety issue: No ]
    Measured by taste, texture, aftertaste, and odour.


Enrollment: 149
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who are between 13 and 30 weeks pregnant. Participants will be recruited from Shimantik .

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676636

Locations
Bangladesh
International Center for Diarrheal Disease Research
Dhaka, Bangladesh
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
The Sprinkles Global Health Initiative
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Stanley Zlotkin, MD The Hospital for Sick Children
Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01676636     History of Changes
Other Study ID Numbers: 1000032744
Study First Received: August 16, 2012
Last Updated: April 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Pregnancy
Calcium
Supplements

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013