EFFECT OF FOOD ADDITIVES ON HYPERPHOSPHATEMIA AMONG PATIENTS WITH END-STAGE RENAL DISEASE:

A RANDOMIZED CONTROLLED TRIAL

PRESENTED BY: MESHAL SAMADZADA

END-STAGE RENAL DISEASE (ESRD)

Characterized by eGFR < 15 mL/min Depend on dialysis or transplant Kidneys unable to:
excrete waste products maintain fluid/electrolyte balance produce hormones

* Impaired ability to excrete phosphorus

HYPERPHOSPHATEMIA
Elevated phosphorus levels in blood Serum phosphorus > 5.5 mg/dL is associated with 20-40% increase in mortality risk in ESRD patients Involved in development of atherosclerotic heart disease, secondary hyperparathyroidism, and bone disease (renal osteodystrophy)

OBJECTIVE
To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with End-Stage Renal Disease

DESIGN
Cluster randomized controlled trial

14 long-term hemodialysis facilities

Patients receive HD Tx 3 days/week for 3-5hrs Days (Shifts): MWF or TTS
12 offered MWF and TTS 24 shifts 2 offered MWF only 2 shifts Random number generator to assign each shift as: Intervention Group Control Group

ELIGIBILITY CRITERIA
Age 18 years

Receiving long-term HD 6 months

Most recent AND mean serum phosphorus levels > 5.5 mg/dL Before entering study, all patients received regular nutritional care from their facilitys RD
Nutritional status assessment Monthly laboratory result review Education regarding renal diet

BASELINE ASSESSMENT

Medical records of all participants to obtain:

Demographic/Medical characteristics Laboratory test results Current medications

Scale (1-100) used to answer questions regarding:

Urine output Frequency of reading nutrition labels, ingredient lists, and eating fast food Grocery shopping responsibilities Knowledge related to phosphorus content

LABORATORY TEST REVIEW

Serum Albumin
Blood protein; good measure of health in dialysis patients

Serum Calcium and Phosphorus

Low calcium occurs frequently in dialysis patients Balance is important; high Calcium x Phosphorus ratio may cause calcification of soft tissue, joints, vessels

Parathyroid Hormone (PTH)

Increase as calcium levels decline High PTH levels indicate that calcium is being pulled out of bone to maintain calcium homeostasis- can lead to bone pain and fractures

INTERVENTION GROUP
145 participants

First month:
30 minutes nutrition education regarding phosphorus additives/effects Received small magnifier in plastic case Fast-food restaurant handout

Second month:
Telephone intervention
Reinforce instructions/answer questions

CONTROL GROUP
134 participants

First month:
Continued to receive normal care from their facilitys registered dietitians and nephrologists

Second month:
Telephone questionnaire
How often they read nutrition fact labels/ingredient lists, ate meals from fast-food restaurants, received phosphorus-related recommendations from facility dietitian

No education or feedback received

FOLLOW-UP PROCEDURES
Followed up for 3 months until death/moved Medical records to obtain:
Laboratory test results

Patients were asked to:

Identify high-phosphorus foods from same list used for baseline assessment Recall how often they read nutrition fact labels, read ingredient lists, ate meals from fast-food restaurants

OUTCOMES

Primary outcome measure

Change in serum phosphorus level serum phoshorus = final - baseline

Secondary outcomes
Effect of intervention by measuring changes in:
Nutritional/food knowledge Reading ingredient lists Reading nutrition fact labels

RESULTS

IG serum phosphorus = 1.0 mg/dL decrease CG serum phosphorus = 0.4 mg/dL decrease
IG > CG by 0.6 mg/dL

Food knowledge score: IG > CG Reads ingredient list: IG > CG Reads nutrition fact labels: IG > CG

Effect of intervention
Difference in Differences (IG) (CG) *IG improvements statistically greater

IMPLICATIONS
Processed diet is a likely contributor to elevated phosphorus levels Phosphorus-containing additives
Almost 100% absorption

Naturally occurring phosphorus

50-70% absorption

Changes in consumption of phosphorus-containing additives linked to changes in serum phosphorus levels More research is

WHY MIGHT THIS BE DIFFICULT?

High phosphorus content of additive-containing products makes it difficult for patients to adhere to intake guidelines Increased use of phosphorus-containing additives combined with other renal dietary restrictions limits acceptable food choices Ingredient lists often unavailable at fastfood/other restaurants (if they are, they dont include phosphorus content) Phosphorus in additives is more readily absorbed (almost 100%) than from foods naturally high in phosphorus (~60%)

RELATION TO KRAUSES MNT

Prevent or retard development of renal osteodystrophy (bone disease) by controlling calcium, phosphorus, vitamin D, and PTH Prevent deficiency and maintain good nutrition status through adequate protein, energy, vitamin, and mineral intake

Provide initial nutrition education, periodic counseling and long-term monitoring of patients

APPLICATION TO PRACTICE
Monitor patients lab values/overall health
Provide nutrition education Give patients useful tools/practices that are easy to implement