Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
Brief Summary: ABSTRACT

Background:

It is well recognized that excess dietary salt intake plays a major role in the development of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water retention (excess volume) which is associated with hypertension.

Hypotheses:

Hypothesis 1:

Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as assessed by Bioelectrical Impedance Analysis (BIA).

Hypothesis 2:

Dietary salt restriction will result in improved blood pressure control in patients with CKD stages 3-4.

Hypothesis 3:

Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.

Patients and Trial Design: This randomized crossover pilot study is designed to assess the effect of salt restriction on volume status in patients with CKD stages 3 and 4.

Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of \<85 mmol sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary counseling in person at each study visit and at weekly intervals by phone calls from study dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical examination with assessments for weight, blood pressure, pulse, anthropometrics and a standardized clinical assessment of volume status. (ii) volume status using bioelectrical impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance, and serum electrolytes will be assessed for safety.

Data Analysis: BIA measurements in the low salt group will be compared with the regular diet group using the standard linear model analysis for 2x2 crossover trials. Additionally, 24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be compared between the two groups.

Future Implications: A significant reduction in the degree of volume expansion (as assessed by BIA) and blood pressure as a result of a salt restricted diet would have implications for renal and cardiovascular protection and would warrant confirmation by a larger randomized trial.


Options:
A: Arm Label: Diuretic treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Amiloride, Drug: Hydrochlorothiazide | Arm Label: Low-sodium diet; Type: ACTIVE_COMPARATOR; Interventions: Other: Low-sodium diet | Intervention Type: DRUG; Name: Amiloride; Assigned to Arm(s): Diuretic treatment | Intervention Type: DRUG; Name: Hydrochlorothiazide; Assigned to Arm(s): Diuretic treatment | Intervention Type: OTHER; Name: Low-sodium diet; Assigned to Arm(s): Low-sodium diet
B: Arm Label: Study group; Type: EXPERIMENTAL; Interventions: Behavioral: Low-salt educational programme, Behavioral: Low-salt Bangladeshi educational programme | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Low-salt educational programme; Assigned to Arm(s): Study group | Intervention Type: BEHAVIORAL; Name: Low-salt Bangladeshi educational programme; Assigned to Arm(s): Study group | Intervention Type: BEHAVIORAL; Name: Low-salt Bangladeshi educational programme; Assigned to Arm(s): Study group
C: Arm Label: Low Salt Diet; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Low Salt Diet | Arm Label: Ususal Salt Diet; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Usual Salt Diet | Intervention Type: DIETARY_SUPPLEMENT; Name: Low Salt Diet; Assigned to Arm(s): Low Salt Diet | Intervention Type: DIETARY_SUPPLEMENT; Name: Usual Salt Diet; Assigned to Arm(s): Ususal Salt Diet
D: Arm Label: Sequence: ABBA A=usual care, B=self-care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-care management program | Arm Label: Sequence BAAB; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-care management program | Arm Label: Sequence AABB; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-care management program | Arm Label: Sequence BBAA; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-care management program | Intervention Type: BEHAVIORAL; Name: Self-care management program; Assigned to Arm(s): Sequence AABB, Sequence BAAB, Sequence BBAA, Sequence: ABBA A=usual care, B=self-care

Answer: C