The effects of calcitriol and nicotinamide on residual pancreatic beta-cell function in patients with recent-onset Type 1 diabetes (IMDIAB XI).
BACKGROUND
A number of recent studies underline the importance of vitamin D in the pathogenesis of Type 1 diabetes (T1D).


OBJECTIVE
The aim of this study was to investigate whether supplementation with the active form of vitamin D (calcitriol) in subjects with recent-onset T1D protects residual pancreatic beta-cell function and improves glycaemic control (HbA(1c) and insulin requirement).


METHODS
In this open-label randomized trial, 70 subjects with recent-onset T1D, mean age 13.6 years +/- 7.6 sd were randomized to calcitriol (0.25 microg on alternate days) or nicotinamide (25 mg/kg daily) and followed up for 1 year. Intensive insulin therapy was implemented with three daily injections of regular insulin + NPH insulin at bedtime.


RESULTS
No significant differences were observed between calcitriol and nicotinamide groups in respect of baseline/stimulated C-peptide or HbA1c 1 year after diagnosis, but the insulin dose at 3 and 6 months was significantly reduced in the calcitriol group.


CONCLUSIONS
At the dosage used, calcitriol has a modest effect on residual pancreatic beta-cell function and only temporarily reduces the insulin dose.
Pitocco
D
D
Università Cattolica del Sacro Cuore, Ospedale Pediatrico Bambino Gesù, Rome, Italy.
Crinò
A
A
Di Stasio
E
E
Manfrini
S
S
Guglielmi
C
C
Spera
S
S
Anguissola
G Beretta
GB
Visalli
N
N
Suraci
C
C
Matteoli
M C
MC
Patera
I P
IP
Cavallo
M G
MG
Bizzarri
C
C
Pozzilli
P
P
D000293:Adolescent; D001786:Blood Glucose; D002117:Calcitriol / Q000008:administration & dosage*; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin; D050417:Insulin-Secreting Cells / Q000378:metabolism*; D008297:Male; D009536:Niacinamide / Q000008:administration & dosage*; D010865:Pilot Projects
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D009536:Niacinamide; D002117:Calcitriol