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Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial.

ABSTRACT: Vitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects. The safety, especially concerning changes in urinary calcium excretion is of great importance.In a double-blinded, placebo-controlled study in 40 healthy volunteers, we examined the changes in mineral metabolism during supplementation with 3000 IU of oral cholecalciferol daily during 4 months.Both 25(OH)vitamin D and 1,25(OH)2vitamin D increased significantly in the active treated group as compared to the placebo group (186% versus 14% (P<0.001) and 28% versus -8% (P<0.001)). No change was observed in urinary calcium excretion in the active group compared to the placebo group (P?=?0.891). Fibroblast growth factor 23 increased significantly by 10% (P<0.018) in the active group. However, there was no difference in changes in FGF23 between treatment groups (P?=?0.457).High dose cholecalciferol significantly increases 25(OH)vitamin D and 1,25(OH)2vitamin D levels compared to placebo. No changes in urinary calcium excretion or other measured components of the mineral metabolism were found between groups.ClinicalTrials.gov NCT00952562.

SUBMITTER: Nygaard B

PROVIDER: S-EPMC4148309 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial.

Nygaard Birgitte B Frandsen Niels Erik NE Brandi Lisbet L Rasmussen Knud K Oestergaard Ove Vyff OV Oedum Lars L Hoeck Hans Christian HC Hansen Ditte D

PloS one 20140828 8

<h4>Background</h4>Vitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects. The safety, especially concerning changes in urinary calcium excretion is of great importance.<h4>Methods</h4>In a double-blinded, placebo-controlled study in 40 healthy volunteers, we examined the changes in mineral metabolism during supplementation with 3000 IU of oral cholecalciferol daily during 4 months.<h4>Results</h4>Both 25(OH)vitamin D and 1,25(OH)2vitamin D increas ...[more]

PMID: 25166750

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Project description:ImportanceStudies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). To our knowledge, there are no controlled treatment trials with helminth in MS.ObjectiveTo determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS.Design, setting, and participantsThis 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center. Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined).InterventionsPatients were randomized (1:1) to receive either 25 Necator americanus larvae transcutaneously or placebo. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment.Main outcomes and measuresThe primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood.ResultsPatients (mean [SD] age, 45 [9.5] years; 50 women [71%]) were randomized to receive hookworm (35 [49.3%]) or placebo (36 [50.7%]). Sixty-six patients (93.0%) completed the trial. The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-Whitney U tests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 [51.4%] vs 10/36 [27.8%] in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P = .01). No patients withdrew because of adverse effects. There were no differences in adverse events between groups except more application-site skin discomfort in the hookworm group (82% vs 28%). There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo.Conclusions and relevanceTreatment with hookworm was safe and well tolerated. The primary outcome did not reach significance, likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity.Trial registrationClinicalTrials.gov Identifier: NCT01470521.

Dataset Information

Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial.

Publications

Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial.

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