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Completed

NCT Number: NCT01676636

Delivery Vehicles for Prenatal Calcium Supplementation

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.

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Key information

Conditions

Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

International Center for Diarrheal Disease Research, Dhaka, Bangladesh

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acceptability

    Time frame: Day 1, Day 9, Day 16, Day 22

    Measured by colour, preparation, administration.

  2. Ease of Use

    Time frame: Day 1, Day 9, Day 16, Day 22

    Measured by size and ease of swallowing.

  3. Patibility

    Time frame: Day 1, Day 9, Day 16, Day 22

    Measured by taste, texture, aftertaste, and odour.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • The Sprinkles Global Health Initiative

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2012
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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