Evidence map›Paper›PMID 32070323›Full record

ArticleBMC women's health2020

Investigating the effect of vitamin D vaginal suppository on sexual function among postmenopausal women: study protocol for a randomized controlled trial.

Zinat Sarebani, Zainab Alimoradi, Ehsan Aali, Monirsadat Mirzadeh, Venus Chegini, Mohammadreza Abbaspour, Mark D Griffiths

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC women's health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.4field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Zinat SarebaniStudents research committee, School of Nursing & Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran.
Zainab AlimoradiSocial Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Bahonar blv., Qazvin, 34197-59811, Iran. z.alimoradi@qums.ac.ir.ORCID http://orcid.org/0000-0001-5327-2411
Ehsan AaliPharmacology Department, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.
Monirsadat MirzadehCommunity Medicine Department, Metabolic Diseases Research Center, Research Institute For Prevention Of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.
Venus CheginiObstetrics and Gynecology Department, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.
Mohammadreza AbbaspourTargeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Mark D GriffithsPsychology Department, Nottingham Trent University, Nottingham, UK.
Qazvin University of Medical Sciences · IRIranshahr University · IRMashhad University of Medical Sciences · IRNottingham Trent University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMenopause is associated with changes in sexual function which are partly due to vaginal atrophy in response to estrogen reduction. Estrogen administration temporarily reduces the symptoms of vaginal dryness, but long-term exposure to this drug is likely to be associated with serious complications. Considering the promising results of previous studies concerning the effect of vitamin D on vaginal dryness, the proposed study will investigate the effect of vitamin D vaginal suppository on the sexual function of postmenopausal women.

methodsIn a randomized, controlled clinical trial, 105 postmenopausal women will be randomly assigned to three groups receiving vitamin D vaginal suppository, placebo vaginal suppository, or control (no intervention). Vitamin D vaginal suppositories contain 1000 units of vitamin D3. The timing of the use of vitamin D vaginal suppositories and placebo suppositories will be every night in the first 2 weeks, and every other night in the following 6 weeks (8 weeks in total). The primary outcome will be the sexual function of participants which will be assessed using the Female Sexual Function Index (FSFI) before and immediately after the intervention, and at 1 and 2 months after the end of the intervention. The side effects of these suppositories will be examined as a secondary consequence of the study. Data will be analyzed using SPSS software version 25. In the case of normal distribution of data, the mean score of sexual function will be compared between the groups using a repeated measurements ANOVA. If statistical analysis leads to significant results, the post-hoc test will be used to determine the differences between the groups. Comparison of demographic and fertility characteristics of the women will be carried out using statistical tests such as chi-squares and t-tests. A significance level of p < .05 will be used for statistical analyses. DISCUSSION: If vitamin D vaginal suppositories improve sexual function among premenopausal women with long-term effects and minimum side effects, the suppositories will be considered a safe complementary and alternative choice for alleviating sexual dysfunction among this group.

trial registrationIRCT20180704040346N1 at 2018-10-13 prospectively registered.

Indexed as

PostmenopauseAdministration, IntravaginalAgedFemaleHumansMiddle AgedRandomized Controlled Trials as TopicSexual BehaviorSexual Dysfunction, PhysiologicalSuppositoriesTreatment OutcomeVaginaVaginal DiseasesVitamin DSuppositoriesVitamin DMenopauseSexual functionVitamin D vaginal suppository

Identifiers

PMID32070323
PMCPMC7029522
OpenAlexW3007630027

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.