Cornell University-Micronutrient Initiative Calcium Supplementation Study

Preeclampsia Clinical Trial

— MICA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238704
• Other study ID #: IRB #: 1205003071
• Secondary ID: P414/01/2013
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: July 26, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Kenyatta National Hospital/University of Nairobi Ethics Review Committee
• Study type: Interventional

Clinical 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 recommendations.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Dietary Supplement:
• Regimen A calcium and iron/folic acid
Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
• Regimen B calcium and iron/folic acid
Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

Locations

Country	Name	City	State
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	Kakamega

Sponsors (4)

Lead Sponsor	Collaborator
Cornell University	Kenya Ministry of Health, Micronutrient Initiative, University of Nairobi

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks after ANC consultation, during which recruitment into the study occurred	No
Secondary	Adherence to related recommendations	Adherence to other features of the WHO recommendation (taking supplements with food).	8 weeks after ANC consultation, during which recruitment into the study occurred	No
Secondary	Motivation	Motivation scores extracted from the survey instrument administered at follow up.	8 weeks after ANC consultation, during which recruitment into the study occurred	No
Secondary	Self-efficacy	Self-efficacy scores extracted from the survey instrument administered at follow up.	8 weeks after ANC consultation, during which recruitment into the study occurred	No
Secondary	Satisfaction	Satisfaction scores extracted from the survey instrument administered at follow up.	8 weeks after ANC consultation, during which recruitment into the study occurred	No