The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women

NCT03835325, Not applicable, Completed, Eurofarma Laboratorios S.A.; results first posted 2025-04-15

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women	ClinicalTrials.gov
NCT number	NCT03835325	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	80 participants, actual	ClinicalTrials.gov
Lead sponsor	Eurofarma Laboratorios S.A.	ClinicalTrials.gov
Conditions	Memory Disorders, Postmenopausal Symptoms	ClinicalTrials.gov
Interventions	Cogmax®	ClinicalTrials.gov
First posted	2019-02-08	ClinicalTrials.gov
Last updated	2025-04-15	ClinicalTrials.gov
Results first posted	2025-04-15	ClinicalTrials.gov

Registered outcomes 8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Change From Baseline of the Score Number Relative to the Self-efficacy Factor, Consisting of Average Scores on the Domains Capacity, Control and Change of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version	12 weeks after the start of the treatment (Baseline)	The primary outcome measure will evaluate the change from baseline in the score relative to the self-efficacy factor (SEF), consisting of arithmetic average on the domains capacity, control and change of the Meta-memory in Adulthood Questionnaire - Portuguese reduced version (MIAr) SEF final - SEF baseline ≤ 0 (no improvement in the measured memory capacity between the initial and final evaluations) SEF final - SEF baseline \> 0 (improvement in the memory capacity measured between the initial and final evaluations) The arithmetic average on the domains capacity, control and change range from 1 (worse) to 5 (better).	ClinicalTrials.gov
Secondary	Change From Baseline in the Score of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version	12 weeks after the start of the treatment (Baseline)	The short version of Meta-memory in Adulthood Questionnaire is composed of 39 multiple-choice statements that are answered in a five-point likert scale, evaluating seven factors of meta-memory (strategy, task, capacity, change, anxiety, achievement and locus). Secondary Outcome Measures will evaluate the change from baseline of seven factors of meta-memory. The variation of the total sum obtained by means of the MIA questionnaire will be compared between all the visits in which the questionnaire was applied, ie, visit of selection (VS), visit 2 (V2) and final visit (VF).	ClinicalTrials.gov
Secondary	Change From Baseline in Stroop Test Victoria Version	12 weeks after the start of the treatment	Change from Baseline in Stroop Test Victoria version	ClinicalTrials.gov
Secondary	The Overall Assessment of the Effectiveness of the Treatment by the Participant	12 weeks after the start of the treatment	The overall assessment of the effectiveness of the treatment by the participant, through multiple-choice statements in a five-point likert scale 1. My memory worsened in relation to the beginning of this treatment. 2. There has been no improvement in my memory, which remains the same as when I started this treatment. 3. My memory improved a little compared to how it was before the beginning treatment. 4. My memory improved a lot compared to how it was before the beginning of this treatment. 5. My memory returned to normal, that is, it returned to being as before the menopause.	ClinicalTrials.gov
Other	Rate of Discontinuation of Treatment Due to Adverse Events.	12 weeks after the start of the treatment	Rate of discontinuation of treatment due to adverse events.	ClinicalTrials.gov
Other	Changes in Vital Signs (Blood Pressure) at the End of Treatment Compared to Baseline	12 weeks after the start of the treatment	Changes in vital signs (blood pressure) at the end of treatment compared to baseline The blood pressure will be analyzed by the variation of the values measured at each visit in relation to the baseline value (VR), which will be summarized by means of descriptive statistics according to the treatment group.	ClinicalTrials.gov
Other	Changes in Vital Signs (Heart Rate) at the End of Treatment Compared to Baseline	12 weeks after the start of the treatment	Changes in vital signs (heart rate) at the end of treatment compared to baseline The heart rate will be analyzed by the variation of the values measured at each visit in relation to the baseline value (VR), which will be summarized by means of descriptive statistics according to the treatment group.	ClinicalTrials.gov
Other	Changes in Vital Signs (Respiratory Rate) at the End of Treatment Compared to Baseline	12 weeks after the start of the treatment	Changes in vital signs (respiratory rate) at the end of treatment compared to baseline The respiratory rate will be analyzed by the variation of the values measured at each visit in relation to the baseline value (VR), which will be summarized by means of descriptive statistics according to the treatment group.	ClinicalTrials.gov

Outcomes 8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Change From Baseline of the Score Number Relative to the Self-efficacy Factor, Consisting of Average Scores on the Domains Capacity, Control and Change of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version	12 weeks after the start of the treatment (Baseline)	mITT and PP. Efficacy analyzes were performed for the population with modified treatment intent (mITT, n=78)	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change From Baseline in the Score of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version	12 weeks after the start of the treatment (Baseline)				ClinicalTrials.gov
SECONDARY	Change From Baseline in Stroop Test Victoria Version	12 weeks after the start of the treatment				ClinicalTrials.gov
SECONDARY	The Overall Assessment of the Effectiveness of the Treatment by the Participant	12 weeks after the start of the treatment				ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Rate of Discontinuation of Treatment Due to Adverse Events.	12 weeks after the start of the treatment				ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Changes in Vital Signs (Blood Pressure) at the End of Treatment Compared to Baseline	12 weeks after the start of the treatment				ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Changes in Vital Signs (Heart Rate) at the End of Treatment Compared to Baseline	12 weeks after the start of the treatment				ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Changes in Vital Signs (Respiratory Rate) at the End of Treatment Compared to Baseline	12 weeks after the start of the treatment				ClinicalTrials.gov

Results by group 2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source
Change From Baseline of the Score Number Relative to the Self-efficacy Factor, Consisting of Average Scores on the Domains Capacity, Control and Change of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version	Cogmax®	mITT	2.9	Standard Deviation 0.5	score on a scale	ClinicalTrials.gov
Change From Baseline of the Score Number Relative to the Self-efficacy Factor, Consisting of Average Scores on the Domains Capacity, Control and Change of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version	Cogmax®	PP	2.9	Standard Deviation 0.5	score on a scale	ClinicalTrials.gov

Participant flow 3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Cogmax®	80	ClinicalTrials.gov
Overall Study	COMPLETED	Cogmax®	78	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Cogmax®	2	ClinicalTrials.gov

Adverse events 17

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source
other	Gingivitis, Nasopharyngitis and Respiratory tract infection	Infections and infestations	Cogmax®	2	80	3	ClinicalTrials.gov
other	Vascular disorders	Vascular disorders	Cogmax®	25	80	26	ClinicalTrials.gov
other	Metabolism and nutrition disorders	Metabolism and nutrition disorders	Cogmax®	21	80	37	ClinicalTrials.gov
other	Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	Cogmax®	18	80	29	ClinicalTrials.gov
other	Endocrine disorders	Endocrine disorders	Cogmax®	8	80	8	ClinicalTrials.gov
other	Gastrointestinal disorders	Gastrointestinal disorders	Cogmax®	8	80	9	ClinicalTrials.gov
other	Immune system disorders	Immune system disorders	Cogmax®	5	80	5	ClinicalTrials.gov
other	Nervous system disorders	Nervous system disorders	Cogmax®	3	80	4	ClinicalTrials.gov
other	Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	Cogmax®	3	80	3	ClinicalTrials.gov
other	Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	Cogmax®	2	80	2	ClinicalTrials.gov
other	Hepatobiliary disorders	Hepatobiliary disorders	Cogmax®	2	80	2	ClinicalTrials.gov
other	Ear and labyrinth disorders	Ear and labyrinth disorders	Cogmax®	1	80	1	ClinicalTrials.gov
other	Social circumstances	Social circumstances	Cogmax®	1	80	1	ClinicalTrials.gov
other	Cardiac disorders	Cardiac disorders	Cogmax®	1	80	2	ClinicalTrials.gov
other	Reproductive system and breast disorders	Reproductive system and breast disorders	Cogmax®	1	80	1	ClinicalTrials.gov
other	Psychiatric disorders	Psychiatric disorders	Cogmax®	1	80	1	ClinicalTrials.gov
other	Surgical and medical procedures	Surgical and medical procedures	Cogmax®	1	80	1	ClinicalTrials.gov

Adverse event totals 3

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Cogmax®	0	80	ClinicalTrials.gov
Total, other adverse events	Cogmax®	47	80	ClinicalTrials.gov
Total, serious adverse events	Cogmax®	0	80	ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Stroop Color-Word Test	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)