Differences between sun exposure and vitamin D supplementation on blood pressure of pregnant women and size of newborn babies

ISRCTN	ISRCTN87262826
DOI	https://doi.org/10.1186/ISRCTN87262826
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Diponegoro University
Funder	Investigator initiated and funded

Submission date: 27/01/2022
Registration date: 03/02/2022
Last edited: 31/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Vitamin D helps regulate the amount of calcium and phosphate in the body. These nutrients are needed to keep bones, teeth, and muscles healthy.
Vitamin D deficiency in pregnant women is a global health problem in tropical and subtropical countries. This is caused by lack of sun exposure, vitamin D supplementation, and intake of foods containing vitamin D.

Who can participate?
Participants in this study are pregnant women with 20 weeks duration of pregnancy.

What does the study involve?
Participants will have a 25(OH)D examination to know the level of vitamin D, a blood pressure measurement, and a discussion related to pregnancy.

What are the possible benefits and risks of participating?
Benefits: potential health benefit from improved vitamin D intake
Risks: discomfort when having blood taken

Where is the study run from?
Diponegoro University (Indonesia)

When is the study starting and how long is it expected to run for?
March 2021 to May 2022

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Rita Sunarno, sunarno_rita@yahoo.co.id

Contact information

Mrs Rita Sunarno
Principal investigator

Public Health Diponegoro University
Prof.Soedarto Street, No. 1269
Tembalang
Semarang
50275
Indonesia

ORCID ID	0000-0002-9377-582X
Phone	+62 8155614633
Email	sunarno_rita@yahoo.co.id

Study information

Primary study design	Interventional
Study design	Interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Differences in the effect of sun exposure and vitamin D supplementation on blood pressure of pregnant women and anthropometric status of newborn babies
Study objectives	There are differences in the effect of sun exposure and vitamin D supplementation on blood pressure of pregnant women and anthropometric status of newborn babies
Ethics approval(s)	Approved 27/05/2021, Health Research Ethics Committee Faculty of Public Health Diponegoro University (Prof Soedarto No 1269, Tembalang, Semarang 50275, Indonesia; +62 247460044, fkm@undip.ac.id), ref: 165/EA/KEPK-FKM/2021
Health condition(s) or problem(s) studied	Prevention of vitamin D deficiency in pregnant women
Intervention	Participants are randomly divided into three groups using a computerized random number. Group 1 receives standard therapy (Calcium, Fe) plus sun exposure three times every week for 15 - 30 minutes. Group 2 receives standard therapy (Calcium, Fe) plus vitamin D supplementation 1000 IU/day. Group 3 (control group) recieves standard therapy (Calcium, Fe). The intervention starts from 20 weeks gestation. The duration of the intervention is 17 weeks. Every group has 25(OH)D examination before and after the intervention. Each group has a blood pressure examination before intervention and every three weeks. Anthropometric status of the newborn is measured at delivery.
Intervention type	Supplement
Primary outcome measure(s)	25(OH)D is measured using ELFA method before and after intervention
Key secondary outcome measure(s)	1. Blood pressure is measured using a tensimeter before intervention and every three weeks 2. Anthropometry of the newborn is measured using weighing scale and microtoise at delivery
Completion date	31/05/2022

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	Female
Target sample size at registration	108
Total final enrolment	120
Key inclusion criteria	1. Pregnant women with 20 weeks gestation 2. 25(OH)D less than 30 ng/mL
Key exclusion criteria	1. Blood pressure more than 140/90 mmHg 2. Having diabetes therapy 3. Consumed vitamin D supplementation
Date of first enrolment	01/08/2021
Date of final enrolment	31/01/2022

Locations

Countries of recruitment

Indonesia

Study participating centre

Public Health Services in Indonesia

Prof. Soedarto SH street
Tembalang
Semarang
50275
Indonesia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/01/2022: Trial's existence confirmed by Health Research Ethics Committee Faculty of Public Health Diponegoro University.