PregnancyNCT01676636
Delivery Vehicles for Prenatal Calcium Supplementation
An observational study of Pregnancy, run by The Hospital for Sick Children at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Traditional Tablet, Chewable tablets and Unflavoured Powder
- Type of treatment
- Pill or oral medicine
- How many people
- 149 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2012to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who are between 13 and 30 weeks pregnant. Participants will be recruited from Shimantik .
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh
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
- Being tested
- Traditional Tablet, Chewable tablets, Unflavoured Powder, Flavoured Powder
- Keywords
- Pregnancy, Calcium, Supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional TabletDrug
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 tabletsDrug
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 PowderDrug
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 PowderDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Traditional Tablet; Drug: Chewable tablets; Drug: Unflavoured Powder; Drug: Flavoured Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in Consumption of the Calcium Vehicle at day 22
Secondary outcomes (3)
Acceptability
Measured by colour, preparation, administration.
Measured: Day 1, Day 9, Day 16, Day 22
Ease of Use
Measured by size and ease of swallowing.
Measured: Day 1, Day 9, Day 16, Day 22
Patibility
Measured by taste, texture, aftertaste, and odour.
Measured: Day 1, Day 9, Day 16, Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Sprinkles Global Health Initiative, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Stanley Zlotkin, The Hospital for Sick Children
- Investigators
- Stanley Zlotkin, MD, Principal investigator, The Hospital for Sick ChildrenDaniel Roth, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676636
- Sponsor's protocol ID
- 1000032744
- Status last verified
- Apr 2021
- First submitted
- 16 Aug 2012
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24759933
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh
- ClinicalTrials.gov ID
- NCT01676636
- Acronym / sponsor ID
- 1000032744
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Calcium, Supplements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Sprinkles Global Health Initiative, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Drug: Traditional Tablet, Drug: Chewable tablets, Drug: Unflavoured Powder, Drug: Flavoured PowderWomen who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who are between 13 and 30 weeks pregnant. Participants will be recruited from Shimantik .
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional TabletThe 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 | Pregnant Women |
| Chewable tabletsChewable 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 | Pregnant Women |
| Unflavoured PowderThe 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 | Pregnant Women |
| Flavoured PowderThe 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. | Drug | Pregnant Women |
Primary outcome
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.
3 secondary outcomes
Acceptability
Time frame: Day 1, Day 9, Day 16, Day 22
Ease of Use
Time frame: Day 1, Day 9, Day 16, Day 22
Patibility
Time frame: Day 1, Day 9, Day 16, Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 24759933Baxter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley Zlotkin, MD principal investigator
The Hospital for Sick Children
Daniel Roth, MD principal investigator
The Hospital for Sick Children
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by The Hospital for Sick Children at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Consumption of the Calcium Vehicle (time frame: Change from Baseline in Consumption of the Calcium Vehicle at day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01676636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.