FindTrial
Sign In

Vitamin D deficiency in children and adolescents with Type I Diabetes Mellitus: influence of vitamin D supplementation and variations in the Fok-I gen on glycemic control

Vitamin D deficiency in children and adolescents with Type I Diabetes Mellitus: influence of vitamin D supplementation and Fok-I polymorphism on glycemic control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5x82zr
Enrollment
Unknown
Registered
2020-04-30
Start date
2020-03-01
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

Vitamin D deficiency

Interventions

Participants who do not have vitamin D deficiency will be from the control group, while those with vitamin D deficiency will be from the intervention group. The total sample size will be 150 individua
Dietary supplement
C18.452.394.750.124
G07.203.300.456

Sponsors

Universidade Federal do Rio de Janeiro
Lead Sponsor
Instituto de Puericultura e Pediatria Martagão Gesteira
Collaborator

Eligibility

Age
7 Years to 16 Years

Inclusion criteria

Inclusion criteria: Age between 7 and 16 years;diagnosis of type 1 diabetes for at least 1 year

Exclusion criteria

Exclusion criteria: Other autoimmune diseases; sickle cell anemia; kidney or liver disease; genetic syndromes; intestinal malabsorption or hemoglobinopathies; use drugs that affect the metabolism of vitamin D, corticosteroids and insulin pump; and have recently supplemented with vitamin D.

Design outcomes

Primary

MeasureTime frame
Evaluate the glycemic control verified according to the value of HbA1c (%), before and after supplementation with vitamin D and it will be considered a good glycemic control, when the value of HbA1c is less than 7.5%.—

Secondary

MeasureTime frame
It is expected to detect a minimum difference of 15% between two proportions (prevalence of the outcome adequacy of glycemic control - before and after the intervention), using the HbA1c value. The adequacy of vitamin D levels, in the form of 25-OHD, will be obtained by radioimmunoassay by the RIA and DiaSorin kits, using the serum stored in a freezer at -700C. Based on the results found, the study participants will be classified with DVD when 25 (OH) D is less than 30 ng / mL.—

Countries

Brazil

Contacts

Public ContactPatricia;Patricia Padilha;Padilha

Universidade Federal do Rio de Janeiro;Universidade Federal do Rio de Janeiro

patricia@nutricao.ufrj.br;patricia@nutricao.ufrj.br+55-21-999964771;+55-21-999964771

Outcome results

None listed

Source: REBEC (via WHO ICTRP)