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.: PACTR202105843292338 Date of Approval: 25/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of zinc supplementation for treatment of primary dysmenorrhoea among senior secondary students in Alor South-East Nigeria: A double-blind randomized controlled study
Official scientific title ZOFT Trial
Brief summary describing the background and objectives of the trial Primary dysmenorrhoea is one of the commonest gynaecological problems amongst adolescent and young women globally. It is responsible for absenteeism at school and affects performances at work leading to loss of revenues globally. Zinc sulphate is a cheaper dietary supplement with lesser side effects than NSAIDS that has shown some benefits in managing this condition. However, globally there is still scanty evidence to support its efficacy especially in Africa and nigeria specifically. The aims and objectives is to determine the efficacy of zinc sulphate supplementation in the management of primary dysmenorrhoea among senior secondary students
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Primary dysmenorrhoea
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/04/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date 01/10/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Completed
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Zinc group 40mg Three months The intervention group received 40mg of zinc sulphate for the intervention group while the control group received placebo. The medications were indistinguishable from the other in shape, size and color 50
Control Group Placebo 40mg Three months Placebo given at the beginning of the menstrual cycle for three consecutive cycles 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ages between 13-21 Regular menses Has ability to score pain using a 10cm visual analog scale Students with other gynaecological disease Those with secondary dysmenorrhoea Those with a history of chronic illness Those with adverse reaction to zinc Those on hormonal medications or herbal medications Those who refuse to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 21 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 20/10/2020 Nnamdi Azikiwe University Teaching Hospital Nnewi Anambra State
Ethics Committee Address
Street address City Postal code Country
49 Nnewi Onitsha Road Nnewi Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean visual analog score for three cycles At the end of each cycle
Primary Outcome Proportion with nausea and vomiting At the end of each cycle
Secondary Outcome Additional analgesics At the end of each menstrual cycle
Secondary Outcome Allergic reaction At the end of each menstrual cycle
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alor Girls Secondary School Alor Idemili South Nigeria 1 Alor Girls Drive Nnokwa Alor Road Alor Anambra State Alor 434012 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Obiagwu Hillary Dept of Obstetrics and Gynaecology Nauth nnewi Nnewi 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obiagwu Hillary Dept of Obstetrics and Gynaecology Nauth Nnewi Anambra State Nnewi 435101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr George Eleje Dept of Obstetrics and Gynaecology NAUTH Anambra State Nigeria Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hillary Obiagwu obiagwuhillary@yahoo.com +2348037374363 Dept of Obstetrics and Gynaecology Nauth Nnewi Anambra State
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries George Eleje Georgel21@yahoo.com 435101 Dept of Obstetrics and Gynaecology NAUTH Nnewi Anambra State Nigeria
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Associate Professor
Role Name Email Phone Street address
Public Enquiries Ifeanyi Okonkwo Exajay@yahoo.co.uk 08034095756 Dept of Obstetrics and Gynaecology Nauth Nnewi Anambra State Nigeria
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be shared and publicly available Informed Consent Form,Statistical Analysis Plan,Study Protocol Available between September 2021 to March 2022 Open data access
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