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 |
- 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
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
Principal Investigator
Public Health Diponegoro University
Prof.Soedarto Street, No. 1269
Tembalang
Semarang
50275
Indonesia
 ORCID ID |
0000-0002-9377-582X |
|---|---|
| Phone | +62 8155614633 |
| sunarno_rita@yahoo.co.id |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 25(OH)D is measured using ELFA method before and after intervention |
| Secondary outcome measures | 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 |
| Overall study start date | 15/03/2021 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 108, each group consist of 36 participants |
| 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
Tembalang
Semarang
50275
Indonesia
Sponsor information
University/education
Prof. Soedarto SH street, number 1269
Tembalang
Semarang
50275
Indonesia
| Phone | +62 247460020 |
|---|---|
| dkm@live.undip.ac.id | |
| Website | http://www.fkm.undip.ac.id |
"ROR" |
https://ror.org/056bjta22 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
31/01/2022: Trial's existence confirmed by Health Research Ethics Committee Faculty of Public Health Diponegoro University.
