Salt reduction intervention: a cluster randomized trial in northern Thailand
- Conditions
- Cadiovascular diseaseCirculatory SystemCardiovascular disease, unspecified
- Registration Number
- ISRCTN39416277
- Lead Sponsor
- Ministry of Education, Culture, Sports, Science and Technology (Japan)
- Brief Summary
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22947342 2. 2020 results in https://pubmed.ncbi.nlm.nih.gov/33457153/ (added 19/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 753
1. Diabetic patients with high risk of cardiovascular risk by General Framingham scoring 10 years risk (>15%)
2. Hypertensive patients with high risk of cardiovascular risk by Framingham scoring (>15%)
3. Patient who are willing to participate in the study
1. Any female patients who are pregnant
2. Patients aged younger than 35 years
3. Patients with documented type I diabetes
4. Those on long term steroid therapy (more than 2 weeks)
5. Those on long term non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. every day for at least one year)
6. Patients with cancer
7. Patients with known secondary hypertension such as primary aldosteronism, cushing disease syndrome or Pheochromocytoma
8. Patients with severe chronic pulmonary diseases using home oxygen therapy
9. Patients with chronic renal disease (Creatinine?2.0 mg/dl)
10. Patients with Congestive Heart Failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Blood pressure<br> 2. Omron Digital BP monitor HEM 907<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Behaviour change: salt intake estimated by urine sodium using KME-03<br> 2. Clinical outcome: cardiovascular disease (CVD) risk measured using the General Framingham Score (10 year risk)<br> 3. CVD incidence: diagnosis of each CVD event<br> 4. Surrogate outcome: retinal caliber<br>