AzTrials
AzTrials

PreeclampsiaMICANCT02238704

Cornell University-Micronutrient Initiative Calcium Supplementation Study

A study testing Regimen A calcium and iron/folic acid and Regimen B calcium and iron/folic acid in people with Preeclampsia, run by Cornell University at 16 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related… Read more about this study

Who is it for?
Ages 15 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Preeclampsia
What is being tested?
Regimen A calcium and iron/folic acid and Regimen B calcium and iron/folic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,032 participants
Where
16 sitesKenya
Study dates
Sep 2014to Jun 2016
Phase
Interventional
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 15 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Attendance at ANC clinic in a primary care facility in Kakamega north

Who cannot join

  • Gestational age < 16 weeks,
  • Gestational age > 30 weeks,
  • Dietary or medicinal consumption of adequate calcium (according to the screening survey),
  • Intention to leave study community before 8weeks from date of interview

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Kenya16 sites

  • Chebwayi Health centre

    Kakamega

  • Chegulo Health centre

    Kakamega

  • Chevoso Health centre

    Kakamega

  • Chimoi dispensary

    Kakamega

  • Chombeli Health centre

    Kakamega

  • Imbiakhalo Health centre

    Kakamega

  • Kimangeti Health centre

    Kakamega

  • Kuvasali Health centre

    Kakamega

  • Malava district hospital

    Kakamega

  • Manda Health centre

    Kakamega

  • Miting'ongo Health centre

    Kakamega

  • Mugai Health centre

    Kakamega

  • Namagara Health centre

    Kakamega

  • Shamberere Health centre

    Kakamega

  • Shihome Health centre

    Kakamega

  • Shivanga Health centre

    Kakamega

Other trials in Kenya

About this study

Official title: A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations

The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.

Read the detailed description

This study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current WHO recommendation. The comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard) and was found to be burdensome in qualitative studies. The experimental arm, Regimen A, prescribes 2 doses per day and has been associated with greater satisfaction. On face value Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE. We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed 15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total amount of supplement ingested (within a 15% margin of inferiority).

Conditions
Preeclampsia
Being tested
Regimen A calcium and iron/folic acid, Regimen B calcium and iron/folic acid
Keywords
Adherence, Calcium supplementation, Prevention of preeclampsia, Adherence to calcium supplementation
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regimen A calcium and iron/folic acidDietary supplement

    Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

  • Regimen B calcium and iron/folic acidDietary supplement

    Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

Study groups in NCT02238704
Study groupRoleWhat they receive
Regimen AExperimental500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 2 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day
Receives: Dietary Supplement: Regimen A calcium and iron/folic acid
Regimen BActive comparator500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 3 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day
Receives: Dietary Supplement: Regimen B calcium and iron/folic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of calcium supplement ingested

    This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation.

    [Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)] X 100

    Measured: 8 weeks after ANC consultation, during which recruitment into the study occurred

Secondary outcomes (4)

  1. Adherence to related recommendations

    Adherence to other features of the WHO recommendation (taking supplements with food).

    Measured: 8 weeks after ANC consultation, during which recruitment into the study occurred

  2. Motivation

    Motivation scores extracted from the survey instrument administered at follow up.

    Measured: 8 weeks after ANC consultation, during which recruitment into the study occurred

  3. Self-efficacy

    Self-efficacy scores extracted from the survey instrument administered at follow up.

    Measured: 8 weeks after ANC consultation, during which recruitment into the study occurred

  4. Satisfaction

    Satisfaction scores extracted from the survey instrument administered at follow up.

    Measured: 8 weeks after ANC consultation, during which recruitment into the study occurred

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,032 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02238704
Sponsor's protocol ID
IRB #: 1205003071
Other IDs
P414/01/2013
Acronym
MICA
Status last verified
Jul 2016
First submitted
5 Sep 2014
Last updated
27 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Martin SL, Wawire V, Ombunda H, Li T, Sklar K, Tzehaie H, Wong A, Pelto GH, Omotayo MO, Chapleau GM, Stoltzfus RJ, Dickin KL. Integrating Calcium Supplementation into Facility-Based Antenatal Care Services in Western Kenya: A Qualitative Process Evaluation to Identify Implementation Barriers and Facilitators. Curr Dev Nutr. 2018 Aug 23;2(11):nzy068. doi: 10.1093/cdn/nzy068. eCollection 2018 Nov.

    PubMed 30402593

  • Omotayo MO, Dickin KL, Pelletier DL, Mwanga EO, Kung'u JK, Stoltzfus RJ. A Simplified Regimen Compared with WHO Guidelines Decreases Antenatal Calcium Supplement Intake for Prevention of Preeclampsia in a Cluster-Randomized Noninferiority Trial in Rural Kenya. J Nutr. 2017 Oct;147(10):1986-1991. doi: 10.3945/jn.117.251926. Epub 2017 Sep 6.

    PubMed 28878035

  • Martin SL, Omotayo MO, Pelto GH, Chapleau GM, Stoltzfus RJ, Dickin KL. Adherence-Specific Social Support Enhances Adherence to Calcium Supplementation Regimens among Pregnant Women. J Nutr. 2017 Apr;147(4):688-696. doi: 10.3945/jn.116.242503. Epub 2017 Mar 1.

    PubMed 28250195

Questions about this trial

What is this clinical trial studying?

A study testing Regimen A calcium and iron/folic acid and Regimen B calcium and iron/folic acid in people with Preeclampsia, run by Cornell University at 16 sites in Kenya.

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 1 inclusion and 4 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 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Kenya. 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?

Amount of calcium supplement ingested (time frame: 8 weeks after ANC consultation, during which recruitment into the study occurred). 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 NCT02238704, which also lists 3 linked publications.

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 27 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in