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Response to Different Doses of Vitamin D Supplementation in Individuals with Obesity: A Randomized Clinical Trial

Vitamin D deficiency in individuals with obesity, with and without diabetes: association with genetic and non-genetic factors and response to different forms of supplementation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5h255qr
Enrollment
Unknown
Registered
2022-07-11
Start date
2021-09-24
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Obesity

Interventions

In this study, 310 white individuals with obesity and 25-hydroxyvitamin D levels less than 20 ng/mL, will be randomized (155 in each group) to receive a usual dose (14000 international units) or highe
reasons that determined the skin color phenotype.
D04.210.500.247.222.159

Sponsors

Hospital de Clínicas de Porto Alegre
Lead Sponsor
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: White individuals; obesity (body mass index greater than or equal to 30 Kg/m²); 25-hydroxyvitamin D levels less than 20 ng/mL.

Exclusion criteria

Exclusion criteria: Medications that may affect vitamin D levels; kidney disease; liver disease; bone disorders; absorptive disorders.

Design outcomes

Primary

MeasureTime frame
It is expected that there will be no difference between the percentage of patients who achieve vitamin D sufficiency (above 30 ng/dL) at the end of 24 weeks among both groups.—

Secondary

MeasureTime frame
We expect to find an association between the presence of polymorphisms in the GC (rs2282679, rs4588, rs7041) and CYP2R1 (rs10741657, rs12794714, rs1076197, rs1562902) genes with serum vitamin D levels and response to vitamin D3 supplementation.—

Countries

Brazil

Contacts

Public ContactLuis Santos Canani

Hospital de Clínicas de Porto Alegre

lcanani@hcpa.edu.br+55-51-37796400

Outcome results

None listed

Source: REBEC (via WHO ICTRP)