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Comparison of Vitamin D Supplements in Obese and Healthy Women

Comparison of the effects of supplementation with calcifediol, cholecalciferol, or placebo on plasma vitamin D metabolites and biomarkers of bone metabolism in obese and normal-weight women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9n3dqnn
Enrollment
72
Registered
2026-04-29
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, unspecified Vitamin D

Interventions

This is a randomized, double-blind, controlled clinical trial with two arms. In the experimental group, twelve women with obesity and twelve women with normal BMI will receive cholecalciferol 2,000 IU

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women with obesity (BMI greater than or equal to 30 kg/m²), aged 18 to 60 years, followed at the Obesity Outpatient Clinic. Control group: women with BMI between 18.5 and 24.9 kg/m², aged 18 to 60 years

Exclusion criteria

Exclusion criteria: Age under 18 years; pregnancy or lactation; intestinal malabsorptive disorders; use of medications that interfere with vitamin D metabolism or absorption (corticosteroids, anticonvulsants, isoniazid, antiretrovirals, antifungals, orlistat, cholestyramine); primary/tertiary hyperparathyroidism; hypoparathyroidism; osteoporosis; osteomalacia; rickets; thyrotoxicosis; chronic kidney disease (creatinine clearance under 45 mL/min); history of cancer; chronic liver failure; patient refusal. Use of any commercial vitamin D formulations within the past 2 months

Design outcomes

Primary

MeasureTime frame
A greater and earlier increase in serum 25-hydroxyvitamin D levels is expected in the group receiving calcifediol compared to the groups receiving cholecalciferol or placebo

Secondary

MeasureTime frame
It is expected that a greater decline in serum 25-hydroxyvitamin D levels will be observed 30 days after discontinuation of the capsules in the group that received calcifediol for 90 days, compared to the group that received cholecalciferol for 90 days

Countries

BR

Contacts

Public ContactWesdrey Fernandes

Universidade Federal de São Paulo

wesdrey.fernandes@unifesp.br+55(11)943215382

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026