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.: PACTR202401577278397 Date of Approval: 12/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effects of Vitamin D on risk factors that leads to insulin resistance and glycemic status among Polycystic Ovary patients in a tertiary fertility hospital in Western part of Kenya.
Official scientific title Effects of Vitamin D on predictors of insulin resistance and glycemic status in Polycystic ovary syndrome at Mediheal Fertility Center in Eldoret; Western Kenya
Brief summary describing the background and objectives of the trial Since Achard and Theirs' initial description of "La diabete des femmes a barbe" (diabetes of the bearded ladies) in 1921, insulin resistance and hyperinsulinemia in women with polycystic ovarian syndrome (PCOS) continue to be among the most prevalent metabolic issues. Type II diabetes mellitus and insulin resistance affect around 70% of women with PCOS. Inconsistent study findings and the lack of a well-established IR mechanism have confounded insulin resistance therapy options and PCOS care in general. According to research, 80 percent of PCOS-afflicted women have vitamin D deficiencies, which may be the missing connection between vitamin D and insulin resistance. The study therefore aims to determine the effects of Vitamin D on insulin resistance and glycemic status in PCOS patients attending Mediheal Fertility Center in Western part of Kenya. The study will further examine the effects of Vitamin D on various hormones, including Testosterone, LH, insulin and Antimullerian hormone. It will also investigate the impact on Cytokine markers such as Interleukin 2,4,6,10 AND Tumor necrotic factor . Additionally, this study will assess changes in lipid profile; Total cholesterol, Triglycerides, High density lipoprotein and Low-density lipoprotein, fasting blood sugars, cytokin, glycaemic status markers; Hemoglobin A1C and anthropometric changes; Body mass index, waist and hip circumference ratios. Through this study, quantitative insulin sensitivity check index and homeostatic model assessment of IR will be determined. The study will be an interventional study using both -Pre-test and Post-test with controls. The sample size of 40 patients with PCOS will be randomized into intervention group (n=20) and positive control (n=20) receiving 50,000 IU/week of Vitamin D plus 500mg/day of Metformin and Metformin 500mg/day only respectively for a period of 12 weeks.
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 Fertility-female
Purpose of the trial Education /Training
Anticipated trial start date 06/11/2023
Actual trial start date 04/12/2023
Anticipated date of last follow up 04/04/2024
Actual Last follow-up date 04/03/2024
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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 D plus Metformin Vitamin D 60,000 iu/week for 12 weeks plus Metformin 500mg/day for 12 weeks 12 weeks The participants are randomly assigned to one of two groups, with the intervention group receiving 50,000 IU of vitamin D + 500 mg of metformin daily (n = 20), and the control group receiving only metformin daily (n = 20) over a 12-week period. Following the consent, the study participants, will be randomly assigned to one of the two groups at the screening point 20
Control Group metformin 500mg once per day for 12 weeks Oral metformin 500mg per day for 12 weeks 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women between 18 and 50 years who will be diagnosed with polycystic ovary syndrome as per Rotterdam Criteria and consents to the study. Pregnant women Patients taking vitamin D supplements other illnesses, such as liver disease, kidney disease, HIV, cancer or thyroid and parathyroid complications, diabetes mellitus, hypertension and heart failure Adult: 19 Year-44 Year 18 Year(s) 50 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 23/11/2023 MOI UNIVERSITY COLLEGE OF HEALTH SCIENCES AND MOI TEACHING AND REFERRAL HOSPITAL JOINT IREC
Ethics Committee Address
Street address City Postal code Country
P.O BOX 4606-ELDORET 30100 ELDORET 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Insulin resistance At the end of 12 weeks
Primary Outcome Effects of Vitamin D on hormonal profiles-,ANTIMULLERIAN,TESTOSTERONE,LH,LIPID PROFILES-total cholesterol,LDL,HDL and Tryglycerides,Cytokines-IL4,IL6,IL2,IL 10 and TNF Alpha,BMI,Waist-Hip ratio,HbA1C AT THE END OF 12 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MEDIHEAL FERTILITY CENTERELDORET NANDI ROAD ELDORET 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
SAVINGS FROM INCOMES NANDI ROAD ELDORET 30100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CYPRIAN MABONGA 6706-30100 ELDORET 30100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CYPRIAN MABONGA cmabonga@kafu.ac.ke +254725767076 6706-30100
City Postal code Country Position/Affiliation
Eldoret Kenya UNIVERSITY LECTURER
Role Name Email Phone Street address
Scientific Enquiries Kavoo Linge kavoolinge@gmail.com +254522085 MOI AVENUE
City Postal code Country Position/Affiliation
NAIROBI Kenya GYNECOLOGIST AND RESEACHER
Role Name Email Phone Street address
Public Enquiries KARANI MAGUTAH kmagutah@gmail.com +254721545063 NANDI ROAD
City Postal code Country Position/Affiliation
ELDORET 30100 Kenya LECTURE AND RESEACHER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I Cyprian Mabonga who is the Principal Investigator within 3 months after completion of the study, I will share the deidentified individual clinical trial participant-level data. The study protocol, statistical analysis plans, the informed consent forms, the clinical study report will be shared via a google drive to PACTR through cmabonga@kafu.ac.ke mail. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 months after completion of the trial Unrestricted access to data
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