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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 November 2015 |
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Main ID: |
NCT02136264 |
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Date of registration:
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08/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Personalized Dietary Intervention for the Control of Essential Hypertension
PCFADASH-HT |
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Scientific title:
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Randomized Controlled Trial of a Personalized Dietary Intervention Approach for the Control of Essential Hypertension |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02136264 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Nnamdi Nwosu, MB BS FWACP |
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Address:
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Telephone:
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+2348037123803 |
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Email:
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dykenig@yahoo.com |
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Affiliation:
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Name:
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Chioli P Chijioke, MA MB BChir MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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College of Medicine, University of Nigeria |
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Name:
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Bridget Nwokolo, BSc Nursing Science |
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Address:
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Telephone:
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+2348060281994 |
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Email:
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bridgetnwokolocd2007@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. average blood pressure exceeds 160/100mm Hg (140/90 if additional vascular risk),
regardless of whether on treatment
2. on one or two antihypertensive drugs AND average BP exceeds 140/90 (130/80 if
additional risk)
3. on three or more antihypertensives, regardless of whether BP controlled
4. sufficiently literate to follow detailed dietary instructions
5. informed consent
Exclusion Criteria:
1. disabling complications of hypertension
2. secondary cause of hypertension
3. pregnancy
4. age less than 18 years
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Essential Hypertension
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Intervention(s)
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Other: PCFA interventional dietary counselling
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Other: conventional DASH diet counselling
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Primary Outcome(s)
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a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
[Time Frame: 2 years]
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Secondary Outcome(s)
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serious (disabling) adverse events attributable to hypertension or its drug treatment
[Time Frame: 2 years]
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resolution of hypertension (normal blood pressure, no drugs required)
[Time Frame: 2 years]
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Secondary ID(s)
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PCFADASH-HT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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