Cornell University-Micronutrient Initiative Calcium Supplementation Study (MICA)

July 26, 2016 updated by: Cornell University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

1032

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kakamega, Kenya
        • Chebwayi Health centre
      • Kakamega, Kenya
        • Chegulo Health centre
      • Kakamega, Kenya
        • Chevoso Health centre
      • Kakamega, Kenya
        • Chimoi dispensary
      • Kakamega, Kenya
        • Chombeli Health centre
      • Kakamega, Kenya
        • Imbiakhalo Health centre
      • Kakamega, Kenya
        • Kimangeti Health centre
      • Kakamega, Kenya
        • Kuvasali Health centre
      • Kakamega, Kenya
        • Malava district hospital
      • Kakamega, Kenya
        • Manda Health centre
      • Kakamega, Kenya
        • Miting'ongo Health centre
      • Kakamega, Kenya
        • Mugai Health centre
      • Kakamega, Kenya
        • Namagara Health centre
      • Kakamega, Kenya
        • Shamberere Health centre
      • Kakamega, Kenya
        • Shihome Health centre
      • Kakamega, Kenya
        • Shivanga Health centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen A
500mg 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
Dietary supplement: Regimen A calcium and iron/folic acid
Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
Active Comparator: Regimen B
500mg 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
Dietary supplement: Regimen B calcium and iron/folic acid
Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of calcium supplement ingested
Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to related recommendations
Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
Adherence to other features of the WHO recommendation (taking supplements with food).
8 weeks after ANC consultation, during which recruitment into the study occurred
Motivation
Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
Motivation scores extracted from the survey instrument administered at follow up.
8 weeks after ANC consultation, during which recruitment into the study occurred
Self-efficacy
Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
Self-efficacy scores extracted from the survey instrument administered at follow up.
8 weeks after ANC consultation, during which recruitment into the study occurred
Satisfaction
Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
Satisfaction scores extracted from the survey instrument administered at follow up.
8 weeks after ANC consultation, during which recruitment into the study occurred

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornell University

Collaborators

University of Nairobi
Kenya Ministry of Health
Micronutrient Initiative

Investigators

  • Principal Investigator: Katherine Dickin, PhD, Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #: 1205003071
  • P414/01/2013 (Other Identifier: Kenyatta National Hospital Ethics Review Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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