Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202109528354413 Date of Approval: 30/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Vitamin B-complex and Oral Health in Postmenopausal Women
Official scientific title Effect of Vitamin B-complex on Oral Mucosa and Oral Health Related Quality of Life among Postmenopausal Women: Randomized Trial
Brief summary describing the background and objectives of the trial BACKGROUND: Postmenopausal women constitute a reasonable proportion of the population, thus investigating their oral health challenges with a view to providing a success-oriented solution is deemed necessary. OBJECTIVE: To determine oral mucosal status, salivary flow rate and oral health-related quality of life among postmenopausal women and to ascertain the effect of vitamin B-complex supplement on the oral mucosal status, salivary flow rate and oral health-related quality of life.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 29/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin B complex 370mg 12hourly Four weeks the participants will be given tablets 370mg of vitamin B complex 12 hourly for 4weeks and reviewed thereafter for the effect on the oral mucosa, salivary flow and oral health related quality of life. 33
Control Group Placebo containing purely maize starch 370mg 12 hourly four weeks the participants will be given tablets 370mg of purely maize starch 12 hourly for 4weeks and reviewed thereafter for the effect on the oral mucosa, salivary flow and oral health related quality of life. 33 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1)Postmenopausal women, defined as women 12 months and above after their last menstruation attending the Outpatient Clinics, who signed informed consent form and complied with the research protocol 2)Postmenopausal women without history of Sjogren’s syndrome or fibrosis of salivary glands. 3)Postmenopausal women not on any drug known to cause xerostomia, examples are tricyclic antidepressants and antihistamines 1)Postmenopausal women attending the outpatient Clinics who did not sign informed consent form. 2) Focal infection and fibrosis of the major salivary glands due to Sjögren’s syndrome, Mikulicz disease, Dehydration, Autoimmune diseases, Post radiotherapy changes, Chemotherapy and those postmenopausal women receiving treatment for xerostomia or osteoporosis. 3)Postmenopausal women attending the outpatient Clinic of University of Benin Teaching Hospital with diabetes mellitus, celiac disease, HIV, Crohn’s disease, alcohol dependence, kidney conditions, rheumatoid arthritis, ulcerative colitis and inflammatory bowel disease that prevent the body from properly absorbing vitamin B-complex. 4)Postmenopausal women attending the outpatient Clinic who are unable to take vitamin B complex tablets for medical reasons and otherwise. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 55 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/08/2021 Health Research Ethics Committee University of Benin teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ugbowo Benin City PMB 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Salivary flow rate Baseline and after 4weeks
Primary Outcome Salivary pH Baseline and after 4weeks
Secondary Outcome Salivary viscosity Baseline and after 4weeks
Primary Outcome Oral Health related quality of Life Baseline and after 4weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital Ugbowo Benin City Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nwauzor Eze Stephen Ugbowp Benin City Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nwauzor Eze Stehen ugbowo Benin City Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eze Stephen Nwauzor stepheneze1970@gmail.com 08134290606 Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Registrar University of Benin Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Eze Stephen Nwauzor stepheneze1970@gmail.com 08134290606 Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Registrar University of Benin Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Eze Stephen Nwauzor stepheneze1970@gmail.com 08134290606 Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Registrar University of Benin Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Salivary flow rate, salivary pH, Salivary viscosity, Oral mucosa health and Oral Heath related quality of life will be shared excluding data on personal identifier Informed Consent Form,Study Protocol 2 years Controlled access, unlimited analysis, third party can grant access to specialist in Oral Medicine, Obstetrics and Gynecology, Public Health.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information