Please select the arm or intervention descriptions that belong 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: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Dietary sodium reduction; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary sodium reduction | Intervention Type: BEHAVIORAL; Name: Dietary sodium reduction; Assigned to Arm(s): Dietary sodium reduction
B: Arm Label: Normal Salt; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Regular Salt | Arm Label: Salt Substitute; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Salt Substitute | Intervention Type: DIETARY_SUPPLEMENT; Name: Regular Salt; Assigned to Arm(s): Normal Salt | Intervention Type: DIETARY_SUPPLEMENT; Name: Salt Substitute; Assigned to Arm(s): Salt Substitute
C: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Reduced-sodium added-potassium salt substitute; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary sodium reduction | Intervention Type: BEHAVIORAL; Name: Dietary sodium reduction; Assigned to Arm(s): Reduced-sodium added-potassium salt substitute
D: Arm Label: Na salt; Type: PLACEBO_COMPARATOR; Interventions: Other: Regular salt | Arm Label: K salt; Type: ACTIVE_COMPARATOR; Interventions: Other: Potassium-enriched salt | Arm Label: K/Mg salt; Type: ACTIVE_COMPARATOR; Interventions: Other: Potassium and magnesium-enriched salt | Intervention Type: OTHER; Name: Regular salt; Assigned to Arm(s): Na salt | Intervention Type: OTHER; Name: Potassium-enriched salt; Assigned to Arm(s): K salt | Intervention Type: OTHER; Name: Potassium and magnesium-enriched salt; Assigned to Arm(s): K/Mg salt

Answer: C