Delivery Vehicles for Prenatal Calcium Supplementation

NCT01676636 | Completed

• 1 other identifier: 1000032744
• Study Type: observational
• Target: 149
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Pregnancy

Keywords

Pregnancy; Calcium; Supplements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Acceptability

  Day 1, Day 9, Day 16, Day 22

• Ease of Use

  Day 1, Day 9, Day 16, Day 22

• Patibility

  Day 1, Day 9, Day 16, Day 22

Study Arms (1)

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; Drug: Chewable tablets; Drug: Unflavoured Powder; Drug: Flavoured Powder

Interventions

Traditional Tablet DRUG

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.

Pregnant Women

Chewable tablets DRUG

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.

Pregnant Women

Unflavoured Powder DRUG

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.

Pregnant Women

Flavoured Powder DRUG

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.

Pregnant Women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Sprinkles Global Health Initiative: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (2)

International Center for Diarrheal Disease Research

Dhaka, Bangladesh

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 24759933 DERIVED

Study Officials

• Stanley Zlotkin, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Daniel Roth, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Global Child Health

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 31, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

BA (1); CA (1)