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Trial record 99 of 123 for:    hypertension "vitamin d"

Cornell University-Micronutrient Initiative Calcium Supplementation Study (MICA)

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ClinicalTrials.gov Identifier: NCT02238704
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : July 27, 2016
Sponsor:
Collaborators:
Kenya Ministry of Health
University of Nairobi
Micronutrient Initiative
Information provided by (Responsible Party):
Cornell University

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Dietary Supplement: Regimen A calcium and iron/folic acid Dietary Supplement: Regimen B calcium and iron/folic acid Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238704


Locations
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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, Kenya
Sponsors and Collaborators
Cornell University
Kenya Ministry of Health
University of Nairobi
Micronutrient Initiative
Investigators
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Principal Investigator: Katherine Dickin, PhD Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT02238704     History of Changes
Other Study ID Numbers: IRB #: 1205003071
P414/01/2013 ( Other Identifier: Kenyatta National Hospital Ethics Review Committee )
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

Keywords provided by Cornell University:
Adherence
Calcium supplementation
Prevention of preeclampsia
Adherence to calcium supplementation

Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pre-Eclampsia
Pregnancy Complications
Calcium
Calcium, Dietary
Iron
Folic Acid
Vitamin B Complex
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Hematinics
Vitamins