Evidence map›Paper›PMID 37929406›Full record

Trial reportIndian journal of pharmacology

Efficacy, safety, and dose-response effects of calcifediol supplementation on 25-hydroxyvitamin D, parathyroid hormone, and 1,25-dihydroxyvitamin D levels in healthy adults: An open-label, interventional pilot study.

Liza Das, Michael F Holick, Naresh Sachdeva, Sanjay Kumar Bhadada, Shallu Singhmar, Neetika Thakur, Pinaki Dutta, Raman Kumar Marwaha

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Indian journal of pharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Liza DasDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Michael F HolickDepartment of Medicine, Section of Endocrinology, Diabetes, Nutrition and Weight Management, Boston University School of Medicine, Boston, Massachusetts, USA.
Naresh SachdevaDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Sanjay Kumar BhadadaDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Shallu SinghmarDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Neetika ThakurDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Pinaki DuttaDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Raman Kumar MarwahaEndocrinology, Society of Endocrine Health Care for Elderly, Adolescents and Children, New Delhi, India.
Post Graduate Institute of Medical Education and Research · INBoston University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitamin D deficiency (VDD) is highly prevalent across the globe. Cholecalciferol (Vitamin D3) fails to attain sufficient serum concentrations of 25-hydroxyvitamin D (25(OH)D) in a significant proportion of supplemented individuals. Calcifediol (25-hydroxyvitamin D3) is less studied in healthy adults and its effects on 25(OH)D, parathyroid hormone (PTH), and 1,25-dihydroxyvitamin D (1,25(OH)2D) at higher doses are not well known. MATERIALS AND

methodsThe study was an open-label, interventional trial recruiting consecutive participants with VDD who were allocated to receive either 2 capsules (50 μg-group) or 1 capsule (25 μg-group) daily doses of calcifediol. Baseline assessment included clinicodemographic parameters, dietary calcium, calcemic (calcium, inorganic phosphate, albumin, alkaline phosphatase, urine spot calcium/creatinine), and hormonal parameters (25(OH)D, PTH, and 1,25(OH)2D). Participants were followed up at 4 and 8 weeks with repeat assessments of calcemic and hormonal parameters.

resultsThere were 64 participants, 35 (50 μg-group) and 29 (25 μg-group), without any significant difference in any of the baseline parameters. 97.1% participants in the 50 μg-group (at 4 and 8 weeks) and 93.1% (at 4 weeks) and 96.5% (at 8 weeks) in the 25 μg-group attained 25(OH)D sufficiency (≥30 ng/ml) with calcifediol. The mean serum 25(OH)D was 84.0 ± 27.7 ng/ml in the 50 μg-group and 58.0 ± 23.6 ng/ml in the 25 μg-group group at 4 weeks, which later rose to 94.3 ± 21.8 ng/ml and 76.0 ± 16.4 ng/ml, respectively, at 8 weeks. PTH levels decreased in both groups at both time points. 1,25(OH)2D rose significantly in both groups at 4 and 8 weeks but was not significantly different between both groups. There was no case of incident hypercalcemia or symptomatic nephrolithiasis.

conclusionCalcifediol is a safe and efficacious alternative for oral Vitamin D supplementation in young adults. Increment in 25(OH)D levels is rapid and dose-dependent.

Indexed as

CalcifediolVitamin D DeficiencyCalciumCholecalciferolDietary SupplementsHumansParathyroid HormonePilot ProjectsVitamin DYoung Adult1,25-dihydroxyvitamin D25-hydroxyvitamin DCalcifediolCalciumCholecalciferolParathyroid HormoneVitamin D125-dihydroxyvitamin D25-hydroxyvitamin Dcalcifediolparathyroid hormoneVitamin D supplementation

Identifiers

PMID37929406
PMCPMC10751521
OpenAlexW4388423894

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.