Essential HypertensionPCFADASH-HTNCT02136264
Study of Personalized Dietary Intervention for the Control of Essential Hypertension
A study testing PCFA interventional dietary counselling and conventional DASH diet counselling in people with Essential Hypertension, run by University of Nigeria, Enugu Campus at 1 site in Nigeria.
Trial summary
An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats, and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- PCFA interventional dietary counselling and conventional DASH diet counselling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNigeria
- Study dates
- Jun 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- average blood pressure exceeds 160/100mm Hg (140/90 if additional vascular risk), regardless of whether on treatment
- on one or two antihypertensive drugs AND average BP exceeds 140/90 (130/80 if additional risk)
- on three or more antihypertensives, regardless of whether BP controlled
- sufficiently literate to follow detailed dietary instructions
- informed consent
Who cannot join
- disabling complications of hypertension
- secondary cause of hypertension
- pregnancy
- age less than 18 years
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Chiolive International Medical Research Organisation
Enugu, Enugu State, 400001
Bridget Nwokolo, BSc Nursing Science, +2348060281994, bridgetnwokolocd2007@yahoo.com
Nnamdi Nwosu, MB BS FWACP
About this study
Official title: Randomized Controlled Trial of a Personalized Dietary Intervention Approach for the Control of Essential Hypertension
An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats, and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com). Hence a personalized categorical food avoidance diet averts relapse and maintains remission of psoriasis, with side benefit on blood pressure and other metabolic parameters (J Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis: this dietary approach would improve the control of essential hypertension. A randomized controlled clinical trial is proposed to compare this dietary approach with conventional DASH-type dietary counselling. 40 study participants will be randomly assigned to either conventional or interventional dietary counselling. They will be comprehensively monitored (including gene expression studies) for two years. Outcome criteria will include blood pressure, complications of hypertension, side-benefit on comorbidity, and requirement for antihypertensive drugs.
- Conditions
- Essential Hypertension
- Being tested
- PCFA interventional dietary counselling, conventional DASH diet counselling
- Keywords
- hypertension, dietary intervention, personalized nutrition, randomized controlled trial
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCFA interventional dietary counsellingOther
conventional DASH diet counsellingOther
| Study group | Role | What they receive |
|---|---|---|
| PCFA interventional dietary counselling | Active comparator | personalized categorical food avoidance dietary counselling Receives: Other: PCFA interventional dietary counselling |
| conventional DASH diet counselling | Sham comparator | DASH = conventional "dietary approach to stop hypertension" Receives: Other: conventional DASH diet counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
Measured: 2 years
Secondary outcomes (2)
resolution of hypertension (normal blood pressure, no drugs required)
Measured: 2 years
serious (disabling) adverse events attributable to hypertension or its drug treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nigeria, Enugu Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, University Of Nigeria Teaching Hospital
- Responsible party
- Principal investigator, Dr C.P. Chijioke, University of Nigeria, Enugu Campus
- Investigators
- Chioli P Chijioke, MA MB BChir MD, Principal investigator, College of Medicine, University of Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136264
- Sponsor's protocol ID
- PCFADASH-HT
- Acronym
- PCFADASH-HT
- Status last verified
- Nov 2015
- First submitted
- 8 May 2014
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chijioke CP, Okafor MT, Nubila NI, Onah IC, Chijioke UO, Chigbo NN, Maduka IC, Udoh IP, Eleazar CI, Gbenimachor NM, Mbadiwe NC, Nwadike KI, Anusiem CA, Nwosu NI, Okpe AC, Muobike AT, Nwokolo BA, Udorah MI, Nnadozie OJ, Nwonu PC, Ndiokwelu CI, Okwara CC, Oji LC, Okoli UA, Uamai IM, Anakwue RC, Amah CC, Ironkwe NF, Ekwe EA, Aniagor EN, Ayuk CO, Aneziokoro EA, Onwasigwe CN, Ugwoke U, Ide C, Effiong-Essien CR, Chima-Enema N, Onyia BU, Okwy-Nweke C, Enuka HC, Onwuka-Kalu N, Obiefuna A, Okpara TC, Maduabuchi JU, Okwara CC; (Dietary Intervention Research Group). Personalized Food Avoidance Dietary Approach for Psoriasis and Hypertension: A Case Study and Pilot Trial. Niger J Clin Pract. 2024 Oct 1;27(10):1202-1215. doi: 10.4103/njcp.njcp_152_24. Epub 2024 Oct 30.
PubMed 42041218
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Personalized Dietary Intervention Approach for the Control of Essential Hypertension
- ClinicalTrials.gov ID
- NCT02136264
- Acronym / sponsor ID
- PCFADASH-HT / PCFADASH-HT
- Conditions
- Essential Hypertension
- Keywords
- hypertension, dietary intervention, personalized nutrition, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Nigeria, Enugu CampusUniversity, hospital or other
- Collaborators
- University of Glasgow, University Of Nigeria Teaching Hospital
- Study start
- Jun 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats, and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com). Hence a personalized categorical food avoidance diet averts relapse and maintains remission of psoriasis, with side benefit on blood pressure and other metabolic parameters (J Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis: this dietary approach would improve the control of essential hypertension. A randomized controlled clinical trial is proposed to compare this dietary approach with conventional DASH-type dietary counselling. 40 study participants will be randomly assigned to either conventional or interventional dietary counselling. They will be comprehensively monitored (including gene expression studies) for two years. Outcome criteria will include blood pressure, complications of hypertension, side-benefit on comorbidity, and requirement for antihypertensive drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCFA interventional dietary counselling | Active comparator | Other: PCFA interventional dietary counsellingpersonalized categorical food avoidance dietary counselling |
| conventional DASH diet counselling | Sham comparator | Other: conventional DASH diet counsellingDASH = conventional "dietary approach to stop hypertension" |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- average blood pressure exceeds 160/100mm Hg (140/90 if additional vascular risk), regardless of whether on treatment
- on one or two antihypertensive drugs AND average BP exceeds 140/90 (130/80 if additional risk)
- on three or more antihypertensives, regardless of whether BP controlled
- sufficiently literate to follow detailed dietary instructions
- informed consent
Key exclusion criteria (4 listed)
- disabling complications of hypertension
- secondary cause of hypertension
- pregnancy
- age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCFA interventional dietary counselling | Other | PCFA interventional dietary counselling |
| conventional DASH diet counselling | Other | conventional DASH diet counselling |
Primary outcome
a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
Time frame: 2 years
2 secondary outcomes
resolution of hypertension (normal blood pressure, no drugs required)
Time frame: 2 years
serious (disabling) adverse events attributable to hypertension or its drug treatment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Derived from this study: PubMed 42041218Chijioke CP, Okafor MT, Nubila NI, Onah IC, Chijioke UO, Chigbo NN, Maduka IC, Udoh IP, Eleazar CI, Gbenimachor NM, Mbadiwe NC, Nwadike KI, Anusiem CA, Nwosu NI, Okpe AC, Muobike AT, Nwokolo BA, Udorah MI, Nnadozie OJ, Nwonu PC, Ndiokwelu CI, Okwara CC, Oji LC, Okoli UA, Uamai IM, Anakwue RC, Amah CC, Ironkwe NF, Ekwe EA, Aniagor EN, Ayuk CO, Aneziokoro EA, Onwasigwe CN, Ugwoke U, Ide C, Effiong-Essien CR, Chima-Enema N, Onyia BU, Okwy-Nweke C, Enuka HC, Onwuka-Kalu N, Obiefuna A, Okpara TC, Maduabuchi JU, Okwara CC; (Dietary Intervention Research Group). Personalized Food Avoidance Dietary Approach for Psoriasis and Hypertension: A Case Study and Pilot Trial. Niger J Clin Pract. 2024 Oct 1;27(10):1202-1215. doi: 10.4103/njcp.njcp_152_24. Epub 2024 Oct 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chioli P Chijioke, MA MB BChir MD principal investigator
College of Medicine, University of Nigeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCFA interventional dietary counselling and conventional DASH diet counselling in people with Essential Hypertension, run by University of Nigeria, Enugu Campus at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nnamdi Nwosu, MB BS FWACP (+2348037123803, dykenig@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.