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Influence of calcium and / or vitamin D supplementation in patients with Polycystic Ovarian Syndrome.

Metabolomic analysis in Polycystic Ovarian Syndrome and its application in a randomized clinical trial with calcium and vitamin D supplementation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-986tpd
Enrollment
Unknown
Registered
2019-09-05
Start date
2019-08-01
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

Polycystic Ovarian Syndrome and Health Volunteers

Interventions

Group 1. Control (22 volunteers): three placebo capsules (paraffin) will be administered orally daily for 16 weeks. Group 2. Calcium (22 volunteers): three calcium carbonate capsules will be administ
Dietary supplement
SP6.051.227

Sponsors

Universidade Federal de Minas Gerais - UFMG
Lead Sponsor
Universidade Federal de Minas Gerais - UFMG
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Clinical trial: women with medical diagnosis of Polycystic Ovarian Syndrome; age between 18 and 40 years.

Exclusion criteria

Exclusion criteria: Type II diabetes; autoimmune disease; adrenal, renal and hepatic diseases; thyroid disorders; cancer or tumors; acute inflammatory disease; hyperprolactinemia; hypogonadism and pregnancy. Volunteers treated with the following medications will also be excluded: steroid and non-steroidal anti-inflammatories; isotretinoin; cyclosporin; antiretrovirals; insulin; metformin and oral contraceptives.

Design outcomes

Primary

MeasureTime frame
- Mean difference of at least 5 in the HOMA-B index between supplemented patients and placebo group. - Mean difference of at least 100 ng / ml in CRP dosages between supplemented patients and placebo group. - Mean difference of at least 2.5 mmol / l in nitric oxide dosages between supplemented patients and placebo group.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactJéssica Tosatti

Universidade Federal de Minas Gerais - UFMG

jesstosatti@gmail.com+55 (31) 35864614

Outcome results

None listed

Source: REBEC (via WHO ICTRP)