The main study parameter is the routine measurement of serum phosphate concentrations after 8 and 12 weeks. Other study parameters are compliance to phosphate binders and supplement-related complaints such as nausea, diarrhoea, flushing and itchness…
ID
Source
Brief title
Condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the serum phosphate concentrations in week 8 and
12.
Secondary outcome
Other study parameters are compliance to phosphate binders and
supplement-related complaints such as nausea, diarrhea, flushing and itchiness
that leads to dropout.
Background summary
Despite the repeatedly demonstrated beneficial effect of niacin and its
analogue niacinamide (=nicotinamide) on serum phosphate concentrations, this
has not resulted in their incorporation in (inter)national guidelines. We
previously carried out a pilot study in dialysis patients (not published) which
confirmed the effect on serum phosphate concentrations but also showed that
niacin was badly tolerated by most patients. We suspect that this is the reason
why niacin treatment has not been implemented in the clinic. After we
established in some patients that niacinamide was tolerated much better than
niacin, we decided to study now with niacinamide, more patients, and a better
study design.
Study objective
The main study parameter is the routine measurement of serum phosphate
concentrations after 8 and 12 weeks. Other study parameters are compliance to
phosphate binders and supplement-related complaints such as nausea, diarrhoea,
flushing and itchness that leads to dropouts .
Study design
Randomized, crossover study with niacinamide or placebo for 12 weeks followed
by the alternate intervention for another 12 weeks.
Patients will receive niacinamide or placebo, containing only the carrier
material The patients will receive 1 dose of 250 mg or 1 placebo tablet in the
first 4 weeks, and 2 doses of 250 mg or 2 doses placebotablets in the last 8
weeks.
Intervention
During 12 weeks intake of daily niacinamide followed by placebo daily during 12
weeks or reverse.
Study burden and risks
Niacinamide has a Tolerable Upper Intake Limit (UL) of 900 mg/d (EFSA). This
value has a substantial margin of safety built in to identify this UL as a
value well below the clinical trial values that showed no adverse effects.
Patients who benefit (in terms of decreased serum phosphate concentrations)
will be advised to continue taking the supplements.
Willy Brandtlaan 10
Ede 6716 RP
NL
Willy Brandtlaan 10
Ede 6716 RP
NL
Listed location countries
Age
Inclusion criteria
- Hemodialysis patients
- Adults (* 18 year)
- Stable dialysis state (at least 6 months hemodialysis ) as measured at baseline
Exclusion criteria
- Severely malnourished patients as diagnosed by the dietitian
- Patients who dialyse at night in-hospital
- Language barrier
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50499.081.14 |