Condition category
Pregnancy and Childbirth
Date applied
11/11/2020
Date assigned
17/11/2020
Last edited
17/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Pre-eclampsia is a condition that causes high blood pressure during pregnancy and after labour. It is the third highest cause of maternal death in the world. Vitamin D can counteract the changes in the placenta that cause the clinical symptoms of pre-eclampsia. The aim of this study is to evaluate the benefits of this supplement.

Who can participate?
Women who are pregnant for the first time

What does the study involve?
Participants are randomly allocated to one of two groups. The supplement group takes vitamin D by mouth as one dose per month from the 3rd to the 8th month of pregnancy. The control group will be followed in the antenatal clinic and will receive an iron supplement and anti-parasitic treatment. Blood samples will be collected at the start and the end of the study to measure vitamin D and calcium.

What are the possible benefits and risks of participating?
The participants may benefit from the reputed effects of vitamin D. The possible risks include side effects of vitamin D.

Where is the study run from?
University of Lubumbashi (Congo, Democratic Republic)

When is the study starting and how long is it expected to run for?
May 2017 to June 2021

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Richard Kabuyanga Kabuseba
docrica@hotmail.com, richard.kabuseba@unigom.ac.cd

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Kabuyanga Kabuseba

ORCID ID

Contact details

Camps Des Medecins Goma Nord-Kivu Rdc
Goma
243
Congo
Democratic Republic
+243 (0)99 44 99 001/+243 (0)813130100
docrica@hotmail.com

Type

Scientific

Additional contact

Dr Richard Kabuyanga Kabuseba

ORCID ID

Contact details

Camps Des Medecins Goma Nord-Kivu Rdc
Goma
243
Congo
Democratic Republic
+243 (0)99 44 99 001/+243 (0)813130100
Richard.kabuseba@unigom.ac.cd

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Preclampsia in Kivu: vitamin D levels and impacts of vitamin D supplementation on obstetric-neonatal outcomes in primigravida

Acronym

Study hypothesis

Supplementation of pregnant women with vitamin D improves the health of primigravida (potentially at risk of preeclampsia) and the fetus safely.

Ethics approval

Approved 08/02/2019, Ethics Committee of the University of Lubumbashi (B.P: 1825 Lubumbashi, Democratic Republic of Congo; +243 (0)995258703, +243 (0)997022438; clubabankulu2017@gmail.com, gabybora2003@yahoo.fr, Eth_med@yahoo.fr), ref: UNILU/CEM/125/2019

Study design

Single-blinded randomized clinical trial without placebo

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Preeclampsia

Intervention

Patients will be divided into two groups based on gestational age (randomized into two groups).

Supplemented group: 60,000 IU of vitamin D3 per os in one dose per month from the 3rd (≤15 weeks of amenorrhoea) to the 8th month of pregnancy, i.e. 360,000 IU in total.
Control group: does not receive a placebo but will be followed in the ANC and will receive an iron supplement and anti-parasitic treatment. These are primigravidae recruited with a pregnancy age exceeding 15 weeks during the recruitment period and not having completed the second trimester.

Blood will be collected at the recruitment stage and at the end of the trial to measure vitamin D and calcium. Laboratory monitoring will be performed twice at the 7th month and at the delivery.

Selection and recruitment visit: During the 3rd month visit between 11 and 14 weeks supplemented pregnant women will be identified and their informed consent (written) obtained. Non-supplemented pregnant women are also selected during the ANC.

Visits: The patients will be followed every month during the normal pregnancy follow-up (PNC)
End of study visit: after the 34th week of pregnancy a blood sample will be collected for maternal and neonatal indicators.

Intervention type

Drug

Phase

Not Applicable

Drug names

VITOSSAMIN® D3 (cholecalciferol)

Primary outcome measure

Percentage of patients with preeclampsia during pregnancy, evidenced by the occurrence of hypertension (systolic blood pressure [SBP] greater than or equal to 140 mmHg and/or diastolic blood pressure [DBP] greater than or equal to 90 mmHg, taken twice 4-6 hours apart, at rest) and 2 x proteinuria after 20 weeks of amenorrhoea

Secondary outcome measures

For the patients:
1. Gestational age for any incident and for preeclampsia, measured during antenatal care or other consultations by taking blood pressure, albuminuria measurement to confirm preeclampsia from recruitment (enrollment) to postpartum
2. Other clinical signs: given the atypical forms of preeclampsia, some clinical signs according to ACOG may allow the diagnosis of preeclampsia in the absence of proteinuria. The occurrence of these signs is monitored from the time of enrolment until delivery by means of an anamnesis, clinical and laboratory examination, and the pregnant woman is monitoring the antenatal care, of which she is aware
3. Incidents (eclampsia, detachment of the normally inserted placenta, maternal death) measured according to clinical, paraclinical (ultrasound and biology) examination from enrolment to postpartum (or death)
4. Serum concentration of 25OH-D, measured using iChroma II analyser (Boditech Med Inc, South Korea), at enrollment when the pregnant woman is carrying a pregnancy of age ≤14 weeks of amenorrhoea for the gestates to be supplemented and between 34 weeks of amenorrhoea and delivery (thus two samples for each subject), and for the other group after 14 weeks of amenorrhoea and between 34 weeks of amenorrhea and delivery

In newborns:
1. Birth weight measured using scale at birth
2. Height measured using scale at birth
3. Cranial perimeter measured by tape measure by taking the circumference of the head through the glabella just after delivery
4. Intrauterine growth retardation noted at birth but detected by ultrasound as the pregnant woman is following ANC. Confirmation is done at birth with the use of tables
5. Death in utero observed after inclusion in the cohort (as it can occur at any time) and diagnosed by ultrasound before birth

Overall trial start date

01/05/2017

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Primipara, monoembryonic pregnancy (≤15 weeks of amenorrhoea for pregnant women to be supplemented)

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

672

Participant exclusion criteria

1. IMC <17 and ≥ 30 but before pregnancy
2. Pregnant women suffering from calcium urinary lithiasis, renal failure, poorly controlled hypertension, unbalanced diabetes (fasting blood sugar >7 mmol/l or blood sugar >11 mmol/l), hypercalcemia (>2.65 mmol/l) and other phosphocalcic pathologies, bone diseases, lithium intake, digestive malabsorption

Recruitment start date

01/03/2020

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Congo, Democratic Republic

Trial participating centre

Hopital Provincial Du Nord-Kivu
-
Congo, Democratic Republic

Trial participating centre

Hgr Charite Maternelle
-
Congo, Democratic Republic

Trial participating centre

Hopital De Panzi
-
Congo, Democratic Republic

Trial participating centre

Hopital De Kyeshero
-
Congo, Democratic Republic

Trial participating centre

Hopital Heal Africa
-
Congo, Democratic Republic

Trial participating centre

Hopital De Mwesso
-
Congo, Democratic Republic

Sponsor information

Organisation

University of Lubumbashi

Sponsor details

Faculte de Medecine
Lubumbashi
243
Congo
Democratic Republic
+243 (0)82 73 29 369
jbszkakoma2016@gmail.com

Sponsor type

University/education

Website

https://www.unilu.ac.cd

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol will be available at the end of the study when the results are published. It is not yet available online.

The final research report will be written in collaboration with the aforementioned management team. The biostatistician will be interested in the required analyzes. The final version must be endorsed by the signature of each member of the team as soon as possible after the actual end of the research. The study report will be submitted to the relevant competent authorities when this research is launched.

The principal investigator remains the owner of the data and no use or transmission to a third party can be made without his prior consent. The results will be made public regardless of their trend.

The first signatories of the publications will be the people who actually participated in the development of the protocol and its progress as well as in the drafting of the results.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request at the end of the study according to the sharing policy of the university. The researchers will treat this data in strict anonymity when it is published.

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/11/2020: Trial's existence confirmed by the Ethics Committee of the University of Lubumbashi.