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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505516303679 Date of Registration: 08/05/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pregnancy Maternal Serum Vitamin D Levels & Risk of Pre-eclampsia : A Case Control Pilot Study in Kenya.
Official scientific title Pregnancy Maternal Serum Vitamin D Levels & Risk of Pre-eclampsia : A Case Control Pilot Study in Kenya.
Brief summary describing the background and objectives of the trial Preeclampsia is considered among the top causes of avoidable maternal death in low and middle income countries (LMICs); making it a significant social, economic and healthcare system burden. Maternal vitamin D deficiency could be a key factor in the pathophysiology of pre-eclampsia. Worldwide, the link between vitamin D deficiency and pre-eclampsia still has mixed results, with minimal data on this topic from Africa. This study aims to determine the association between maternal serum vitamin D levels in pregnancy and the risk of preeclampsia in a Kenyan population.
Type of trial Observational
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 Hypertensive Disorders of Pregnancy
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/06/2025
Actual trial start date
Anticipated date of last follow up 30/11/2025
Actual Last follow-up date 30/11/2025
Anticipated target sample size (number of participants) 120
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
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Maternal vitamin D status assessment Single 5 mL venous blood draw per participant to assess Serum 25-hydroxyvitamin D [25(OH)D] levels. Single 5 mL venous blood draw per participant (non-fasting, once only). One-time procedure at enrolment; blood collection and dispatch to laboratory completed within ≈ 2 h. Women without pre-clampsia (controls) will be enrolled, and a trained phlebotomist will collect ~5 mL of maternal venous blood into a serum-separator tube. Samples clot for 30 min at room temperature, then travel in a temperature-monitored cool box (2–8 °C) to the ISO 15189-accredited Laboratory, within 2 h. Serum total 25(OH)D (D₂ + D₃) is quantified using a validated commercial ELISA kit; results will be reported in nmol/L. 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) Maternal age of ≥ 18 years at the time of consent (b) Confirmed singleton pregnancy of ≥28 weeks gestation at the time of consent (c) Planned to receive ongoing prenatal care and delivery at MTRH (d) ability to provide written informed consent. (a) Pre-existing chronic kidney disease (b) Pre-existing parathyroid conditions (c) Those on cardiac medication therapy that includes calcium channel blockers (d) Pre-existing thrombophilia (e) Participating in a similar interventional study Recruitment of cases will occur at the MTRH-Antenatal Ward (AW) and High Risk 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 15/04/2025 Moi Teaching and Referral Hospital Moi University Institutional Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Moi Teaching and Referral Hospital Building, 2nd Floor, Door 219, Nandi Road Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum 25-hydroxy-vitamin D concentration. Mean (±SD) maternal 25(OH)D level (nmol L⁻¹) measured with a commercial ELISA kit. Once at enrolment
Secondary Outcome Association between vitamin-D level and pre-eclampsia risk expressed as an odds ratio (OR) for pre-eclampsia per 10 nmol L⁻¹ decrease in 25(OH)D, and separately for deficiency (< 30 nmol L⁻¹) vs sufficiency (≥ 50 nmol L⁻¹), estimated with multivariable logistic regression. Single blood draw at enrolment with analysis after data lock
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Moi Teaching and Referral Hospital Nandi Road, Uasin Gishu County Eldoret 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Supporting Women in Science Programme Institute for Global Health and Development Aga Khan University 3rd Parklands Avenue, off Limuru Road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Supporting Women in Science Programme Institute for Global Health and Development Aga Khan University 3rd Parklands Avenue, off Limuru Road Nairobi 0100 Kenya University
Secondary Sponsor Bill and Melinda Gates Foundation 500 Fifth Avenue Seattle 98109 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kimbley Asaso Omwodo kimbleyomwodo@alumni.harvard.edu +254705557929 Argwings Kodhek Rd
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya SWIS Interscale Fellow Aga Khan University and University of Oxford
Role Name Email Phone Street address
Public Enquiries Bhavita Kumari bhavita.kumari2@aku.edu +923332577395 Stadium Road
City Postal code Country Position/Affiliation
Karachi Pakistan The Institute for Global Health and Development
Role Name Email Phone Street address
Scientific Enquiries Antoniya Georgieva antoniya.georgieva@wrh.ox.ac.uk +447984090980 OX3 9DU
City Postal code Country Position/Affiliation
Oxford United Kingdom Associate Professor Oxford University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (demographics, obstetric history, parity, gestational age, clinical diagnosis of pre-eclampsia, questionnaire responses on diet and sunlight exposure, serum 25-hydroxy-vitamin D values, outcome variables, and a complete data dictionary) will be shared. Informed Consent Form,Study Protocol Beginning 6 months after first journal publication of the primary results and ending 5 years thereafter (or indefinitely while the repository remains active), but no later than 12 months after primary study completion for the initial upload of summary results. Researchers with a methodologically sound proposal should email the Principal Investigator (kimbleyomwodo@alumni.harvard.edu). A brief analytic plan and evidence of ethics approval must be included. Requestors must sign a standard data-use agreement prohibiting re-identification and commercial use. Decisions will be made within 30 days; data will be provided via a Figshare download link.
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 03/05/2025 clarity of ages included. Adult: 19 Year-44 Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/05/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/05/2025 Updated to total sample size instead of size per group. Experimental Group, Maternal vitamin D status assessment, Single 5 mL venous blood draw per participant to assess Serum 25-hydroxyvitamin D [25(OH)D] levels., Single 5 mL venous blood draw per participant (non-fasting, once only). One-time procedure at enrolment; blood collection and dispatch to laboratory completed within ≈ 2 h., Women without pre-clampsia (controls) will be enrolled, and a trained phlebotomist will collect ~5 mL of maternal venous blood into a serum-separator tube. Samples clot for 30 min at room temperature, then travel in a temperature-monitored cool box (2–8 °C) to the ISO 15189-accredited Laboratory, within 2 h. Serum total 25(OH)D (D₂ + D₃) is quantified using a validated commercial ELISA kit; results will be reported in nmol/L., 120,