Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial to Determine the Effects on Blood Pressure of A Reduced-sodium Added-potassium Salt Substitute Among Adults With Hypertension in India
Brief Summary: Blood pressure is a key modifiable risk factor for cardiovascular disease in India. Drug therapies are highly effective and are recommended by local guidelines to reduce the risks of serious cardiovascular complications. Behavioural approaches to blood pressure control based upon sodium reduction are also recommended but there are no interventions proven effective in India.

Mean sodium intake in India is about 5g/day (equivalent to about 12.5g salt) which is, more than double World Health Organization (WHO) recommendations. Reduced sodium, added potassium salt substitutes have favourable effects on blood pressure in settings where discretionary salt use is high, but have not been tested in India. This single-site, Salt Substitute on blood pressure in India Study will investigate the effects of reduced sodium added potassium salt substitution on blood pressure in rural areas where hypertension is a prevalent disease problem and additional, scalable and affordable interventions are required. The primary objective is to assess the effects of salt substitute on SBP at 3 months follow-up. The secondary objectives are to determine effects on DBP, urinary sodium and potassium levels and to determine acceptability of the salt substitute.

The study will be a double-blinded, randomized-controlled trial done in the Hyderabad region amongst adult volunteers with a history of hypertension diagnosed by a health professional. The main exclusion criteria will be known serous kidney disease or use of potassium containing medications by the individual or others living in the household. Written informed consent will be obtained from potential participants followed by baseline data collection. Eligible individuals will then be assigned at random to receive double-blind salt or salt substitute which will be used to replace all dietary salt used for cooking and seasoning over the next 3 months. Follow-up will be at one and three months after randomisation for blood pressure, urinary electrolytes and acceptability of the intervention.


Options:
A: Inclusion Criteria:

* Disease history
* Prior stroke and/or
* Aged 60 years or over and with uncontrolled high blood pressure (systolic blood pressure \>=140 millimeters of mercury (mmHg) at visit if on blood pressure lowering medication; systolic blood pressure\>=160 millimeters of mercury (mmHg) if not on blood pressure lowering medication)
* Ownership of a phone by the participant or a household member

Exclusion Criteria:

* Participant or family member is using a potassium-sparing diuretic
* Participant or family member is using a potassium supplement
* Participant or family member has serious renal impairment
* Participant or family member has other reason for concern about use of salt substitute
* Participant eats most meals outside the home
* Participant is not expected to live longer than 6 months from the date of assessment as estimated by the village doctor
* Another family member living in the same household has already been included in the study
B: Inclusion Criteria:

* Age 40 years or older
* Resident of Yangbajing Township and Gongtang Village in Tibetan Autonomous Region, People's Republic of China
* Mean Systolic Hypertension (≥ 140 mmHg)

Exclusion Criteria:

* Currently taking any potassium supplements (or lives in household where someone does)
* Previously diagnosed kidney disease or gout (or lives in a household where someone does) and physician considered he/she cannot take salt substitute.
* Any person who intended to use salt outside the assigned treatment salt provide in the study
C: Inclusion Criteria:

* Male or female aged 18 years or over
* History of hypertension diagnosed by a health professional - hypertension may be self-reported and antihypertensive drugs may or may not be used for management. There is no entry criterion based upon blood pressure measurements made at the baseline survey
* Eat most of their meals in the home
* Consent to participate

Exclusion Criteria:

* Participant or family member is using a potassium-sparing diuretic
* Participant or family member is using a potassium supplement
* Participant or family member has known significant renal dysfunction
* Participant or family member has other reason for concern about use of salt substitute
* Participant is not expected to live longer than 6 months from the date of assessment
* Another member of the household is already enrolled in the study
D: Inclusion Criteria:

1. hospitalization within 1 month due to cerebral infarction or hemorrhage;
2. a modified Rankin Score of 4 or less at the time of discharge;
3. an age of 45 or older; and
4. an agreement to prepare foods with salt provided by the project.

Exclusion Criteria:

1. patients with poor kidney function (glomerular filtration rate\<60 ml/min), secondary hypertension, cancer, or liver diseases;
2. patients with eating disorders;
3. patients taking K-sparing medicines;
4. or patients using salt substitutes.

Answer: C