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Short-Term Effects of Escalating Doses of Cholecalciferol on FGF23 and 24,25(OH)2 Vitamin D Levels: A Preliminary Investigation.

  • 2024-10-23
  • Nutrients 16(21)
    • Jessica Pepe
    • Luciano Colangelo
    • Roberta Pilotto
    • Viviana De Martino
    • Carla Ferrara
    • Alfredo Scillitani
    • Mirella Cilli
    • Salvatore Minisola
    • Ravinder Singh
    • Cristiana Cipriani

Study Design

Type
Randomized Controlled Trial (RCT)
Population
27 subjects with 25(OH)D < 30 ng/mL
Methods
Randomized into three groups to receive a single oral dose of 25,000 I.U. or 600,000 I.U. of cholecalciferol or placebo
  • Rigorous Journal

Background

There are few and controversial results on 24,25(OH)2D and FGF23 acute changes following supplementation with cholecalciferol.

Methods

Twenty-seven subjects with 25(OH)D < 30 ng/mL were randomized into three groups to receive a single oral dose of 25,000 I.U. or 600,000 I.U. of cholecalciferol or placebo, respectively. We measured 25(OH)D, 1,25(OH)2D, 24,25(OH)2D, and FGF23 levels at baseline and after 72 h. The 1,25(OH)2D/25(OH)D, 1,25(OH)2D/24,25(OH)2D, and 24,25(OH)2D/25(OH)D ratios were also calculated.

Results

There was an increase in 25(OH)D and 1,25 (OH)2D following both doses of cholecalciferol. In the group administered 600,000 I.U., there was a significant increase in the delta changes in 25(OH)D and 1,25(OH)2D compared to the placebo and in the delta 24,25(OH)D2 compared to the placebo and 25,000 I.U. groups (all p < 0.05). A decrease in both the 1,25(OH)2D/25(OH)D and 1,25(OH)2D/24,25(OH)2D ratio (all p < 0.05) was observed in the 600,000 I.U. group. FGF23 values significantly increased only in the group administered 600,000 I.U.

Conclusions

25(OH)D and 1,25(OH)D levels significantly increased following 600,000 IU cholecalciferol administration compared to 25,000 I.U. and placebo. Following the massive administration of cholecalciferol, the CYP24A1 enzyme is actively involved in catabolism, thus, avoiding toxic effects.

Research Insights

  • Vitamin D→Decreased 1,25-dihydroxyvitamin D to 24,25-dihydroxyvitamin D Ratio

    A decrease in both the 1,25(OH)2D/25(OH)D and 1,25(OH)2D/24,25(OH)2D ratio (all p < 0.05) was observed in the 600,000 I.U. group

    Effect
    Beneficial
    Effect size
    Small
    Dose
    600,000 I.U. single oral dose
  • Vitamin D→Decreased Ratio of 1,25-dihydroxyvitamin D to 25-hydroxyvitamin D

    A decrease in both the 1,25(OH)2D/25(OH)D and 1,25(OH)2D/24,25(OH)2D ratio (all p < 0.05) was observed in the 600,000 I.U. group

    Effect
    Beneficial
    Effect size
    Small
    Dose
    600,000 I.U. single oral dose
  • Vitamin D→Increased 1,25-dihydroxyvitamin D Level

    In the group administered 600,000 I.U., there was a significant increase in the delta changes in 25(OH)D and 1,25(OH)2D compared to the placebo and in the delta 24,25(OH)D2 compared to the placebo and 25,000 I.U. groups (all p < 0.05).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    600,000 I.U. single oral dose
  • Vitamin D→Increased 24,25(OH)2D Level

    In the group administered 600,000 I.U., there was a significant increase in the delta changes in 25(OH)D and 1,25(OH)2D compared to the placebo and in the delta 24,25(OH)D2 compared to the placebo and 25,000 I.U. groups (all p < 0.05).

    Effect
    Neutral
    Effect size
    Small
    Dose
    25,000 I.U. single oral dose
  • Vitamin D→Increased 24,25-dihydroxyvitamin D Level

    In the group administered 600,000 I.U., there was a significant increase in the delta 24,25(OH)D2 compared to the placebo and 25,000 I.U. groups

    Effect
    Beneficial
    Effect size
    Small
    Dose
    600,000 I.U. single oral dose
  • Vitamin D→Increased 25-hydroxyvitamin D Level

    In the group administered 600,000 I.U., there was a significant increase in the delta changes in 25(OH)D and 1,25(OH)2D compared to the placebo

    Effect
    Beneficial
    Effect size
    Small
    Dose
    600,000 I.U. single oral dose
  • Vitamin D→Increased FGF23 Level

    FGF23 values significantly increased only in the group administered 600,000 I.U.

    Effect
    Neutral
    Effect size
    Small
    Dose
    25,000 I.U. single oral dose
  • Vitamin D→Increased Vitamin D Level

    In the group administered 600,000 I.U., there was a significant increase in the delta changes in 25(OH)D and 1,25(OH)2D compared to the placebo and in the delta 24,25(OH)D2 compared to the placebo and 25,000 I.U. groups (all p < 0.05).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    600,000 I.U. single oral dose
  • Vitamin D→Reduced 1,25-Dihydroxyvitamin D to 24,25-Dihydroxyvitamin D Ratio

    A decrease in both the 1,25(OH)2D/25(OH)D and 1,25(OH)2D/24,25(OH)2D ratio (all p < 0.05) was observed in the 600,000 I.U. group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    600,000 I.U. single oral dose
  • Vitamin D→Reduced 1,25-Dihydroxyvitamin D to 25-Hydroxyvitamin D Ratio

    A decrease in both the 1,25(OH)2D/25(OH)D and 1,25(OH)2D/24,25(OH)2D ratio (all p < 0.05) was observed in the 600,000 I.U. group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    600,000 I.U. single oral dose
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