Trial Outcomes & Findings for Study of Dietary Additive Phosphorus on Proteinuria and Fibroblast Growth Factor-23 (NCT NCT02020785)
NCT ID: NCT02020785
Last Updated: 2019-06-05
Results Overview
Two 24-hour urine collections will be collected during the 3rd week of each period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
3 weeks
Results posted on
2019-06-05
Participant Flow
Primary recruitment strategies included mass mailing of study brochures to individuals with self-reported type 2 diabetes in neighboring zip codes and to past and current participants of other research studies.
Participant milestones
| Measure |
Higher Phosphorus Period First, Then Lower Phosphorus Period
Randomized to higher phosphorus period first, then lower phosphorus period second.
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
Lower Phosphorus Period First, Then Higher Phosphorus Period
Randomized to higher phosphorus period first, then lower phosphorus period second.
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
|
|---|---|---|
|
First Intervention (3 Weeks)
STARTED
|
15
|
16
|
|
First Intervention (3 Weeks)
COMPLETED
|
15
|
16
|
|
First Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Weeks)
STARTED
|
15
|
16
|
|
Second Intervention (3 Weeks)
COMPLETED
|
15
|
16
|
|
Second Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Dietary Additive Phosphorus on Proteinuria and Fibroblast Growth Factor-23
Baseline characteristics by cohort
| Measure |
Higher Phosphorus Period Then Lower Phosphorus Period
n=15 Participants
Randomized to higher phosphorus period first, then lower phosphorus period second.
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
Lower Phosphorus Period Then Higher Phosphorus Period
n=16 Participants
Randomized to higher phosphorus period first, then lower phosphorus period second.
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
66.0 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksTwo 24-hour urine collections will be collected during the 3rd week of each period
Outcome measures
| Measure |
Lower Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
Higher Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
|---|---|---|
|
24-hour Urine Albumin Excretion
|
76.4 mg/day
Interval 47.2 to 123.8
|
86.2 mg/day
Interval 51.8 to 143.4
|
PRIMARY outcome
Timeframe: 3 weeksPlasma FGF-23 will be measured at the end of each 3 week period in the morning after an overnight fast. As this is a small pilot study, we will not adjust for multiple comparisons. A p value\<0.05 will be considered statistically significant for both outcomes
Outcome measures
| Measure |
Lower Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
Higher Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
|---|---|---|
|
Fibroblast Growth Factor-23 (FGF-23)
|
128.2 Relative units/ml
Interval 113.1 to 145.3
|
132.6 Relative units/ml
Interval 115.4 to 152.3
|
SECONDARY outcome
Timeframe: 2-3 weeksBlood pressure was measured at the end of weeks 1, 2, and 3. At each visit, 3 readings were obtained in the seated position by trained and certified observers after 5 minutes of rest with an Omron HEM-907 device (Omron Healthcare Inc, Bannockburn, Ill) using a standardized protocol. We used the average of all blood pressure measurements at the end of weeks 1, 2, and 3 for each period.
Outcome measures
| Measure |
Lower Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
Higher Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
|---|---|---|
|
Systolic Blood Pressure
|
128 mmHg
Standard Deviation 15.6
|
126.9 mmHg
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 2-3 weeksBlood pressure measured at the end of weeks 1, 2, and 3. At each visit, 3 readings were obtained in the seated position by trained and certified observers after 5 minutes of rest with an Omron HEM-907 device (Omron Healthcare Inc, Bannockburn, Ill) using a standardized protocol. We used the average of all these readings taken during end of weeks 1, 2, and 3 for each period.
Outcome measures
| Measure |
Lower Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
Higher Phosphorus Period
n=31 Participants
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks
At the beginning of the study participants receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
Patients then randomized to higher phosphorus period or lower phosphorus period first.
Higher phosphorus period: Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
Lower phosphorus period: Commercially-available unaltered food/beverage products without any phosphorus additives given for 3 weeks
|
|---|---|---|
|
Diastolic Blood Pressure
|
70.2 mmHg
Standard Deviation 11.4
|
69.3 mmHg
Standard Deviation 10.8
|
Adverse Events
Higher Phosphorus Period
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Lower Phosphorus Period
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Higher Phosphorus Period
n=31 participants at risk
Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) given for 3 weeks
|
Lower Phosphorus Period
n=31 participants at risk
Commercially-available unaltered food/beverage products without phosphorus additives (\<10mg/d of phosphorus) given for 3 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
61.3%
19/31 • Number of events 19 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
67.7%
21/31 • Number of events 21 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.8%
8/31 • Number of events 8 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
38.7%
12/31 • Number of events 12 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
|
Infections and infestations
Flu-like symptoms
|
3.2%
1/31 • Number of events 1 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
9.7%
3/31 • Number of events 3 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
|
General disorders
Fatigue
|
22.6%
7/31 • Number of events 7 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
22.6%
7/31 • Number of events 7 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
6.5%
2/31 • Number of events 2 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
9.7%
3/31 • Number of events 3 • At the end of each 3 week study period.
Participants were asked at the end of each study period if they experienced possible side effects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place