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Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)

ConditionsPolycystic Ovarian Syndrome in Adolescent FemalesVitamin D Deficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age13-21
SponsorYale University

About this trial

This study is a double blind, placebo controlled, randomized trial of study subjects with PCOS and low vitamin D to 2 groups- placebo and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Other causes for hyperandrogenism,

Chronic renal diseases,

Acquired or inherited calcium and vitamin D metabolic disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D 4000IU daily

    Drug

    Randomized to receive vitamin D 4000IU daily

  • Placebo

    Drug

    Randomized to placebo daily

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Vitamin D SupplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in oligomenorrhea

The change in oligomenorrhea, i.e restoration of monthly menses or improvement in the menstrual pattern during 6 months while enrolled in the trial based on self report

Time frame
6 months
2

Changes Vitamin D (25-hydroxyvitamin D) level

25-hydroxyvitamin D level will be measured by liquid chromatography-mass spectrometry (LC-MS/MS) or immunoassay

Time frame
at enrollment, at 3 months after randomization and 6 months after randomization

Secondary outcomes

1

Change in DHEAS level

The serum DHEA-S concentration is the traditional marker for adrenal androgen excession because it is produced almost exclusively by the adrenal glands and concentrations remain stable across the day and cycle. Preferred testing is done by immunoassay.

Time frame
at enrollment, at 3 months after randomization and 6 months after randomization
2

Changes in Androstenedione level

Androstenedione concentration assesses for hyperandrogenemia as well, it is produced by the ovary and the adrenal cortex and serves as precursor of testosterone. Data suggests that levels are elevated in approximately 20% of women with PCOS. Evaluation is done by Liquid Chromatography/Tandem Mass Spectrometry

Time frame
at enrollment, at 3 months after randomization and 6 months after randomization
3

Change in Anti-Mullerian hormone (AMH) level

AMH is a dimeric glycoprotein of the transforming growth factor-β superfamily that is involved in growth and differentiation of ovarian follicles. AMH is expressed in granulosa cells in the ovary and serves as a marker of ovarian reserve as well as marker of several ovarian pathologies such as PCOS, granulosa cell tumors and premature ovarian insufficiency. Level will be measured using Immunoassay (IA)

Time frame
at enrollment, at 3 months after randomization and 6 months after randomization
4

Change in testosterone level

Testosterone levels are elevated in vast majority of adolescents with PCOS. The free testosterone level is more sensitive for diagnosis of hyperandrogenic disorders compared with the total testosterone. Evaluation is done by Chromatography/Mass Spectrometry

Time frame
at enrollment, at 3 months after randomization and 6 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov
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