Clinical trial NCT02238704: Cornell University-Micronutrient Initiative Calcium Supplementation 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Keywords: Adherence
Calcium supplementation
Prevention of preeclampsia
Adherence to calcium supplementation
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Kenya Ministry of Health
name: University of Nairobi
name: Micronutrient Initiative
First posted: 2014-09-12
Enrollment: 1032
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Amount of calcium supplement ingested
timeFrame: 8 weeks after ANC consultation, during which recruitment into the study occurred
Secondary outcomes:
measure: Adherence to related recommendations
timeFrame: 8 weeks after ANC consultation, during which recruitment into the study occurred
measure: Motivation
timeFrame: 8 weeks after ANC consultation, during which recruitment into the study occurred
measure: Self-efficacy
timeFrame: 8 weeks after ANC consultation, during which recruitment into the study occurred
measure: Satisfaction
timeFrame: 8 weeks after ANC consultation, during which recruitment into the study occurred
Other outcomes:
Locations:
city: Kakamega
country: Kenya
facility: Chebwayi Health centre
city: Kakamega
country: Kenya
facility: Chegulo Health centre
city: Kakamega
country: Kenya
facility: Chevoso Health centre
city: Kakamega
country: Kenya
facility: Chimoi dispensary
city: Kakamega
country: Kenya
facility: Chombeli Health centre
city: Kakamega
country: Kenya
facility: Imbiakhalo Health centre
city: Kakamega
country: Kenya
facility: Kimangeti Health centre
city: Kakamega
country: Kenya
facility: Kuvasali Health centre
city: Kakamega
country: Kenya
facility: Malava district hospital
city: Kakamega
country: Kenya
facility: Manda Health centre
city: Kakamega
country: Kenya
facility: Miting'ongo Health centre
city: Kakamega
country: Kenya
facility: Mugai Health centre
city: Kakamega
country: Kenya
facility: Namagara Health centre
city: Kakamega
country: Kenya
facility: Shamberere Health centre
city: Kakamega
country: Kenya
facility: Shihome Health centre
city: Kakamega
country: Kenya
facility: Shivanga Health centre
Study officials:
affiliation: Cornell University
name: Katherine Dickin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.