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PregnancyPhase 1AViDD-1NCT00938600

Antenatal Vitamin D3 Dose-finding and Safety Study

A Phase 1 study testing Vitamin D3 in people with Pregnancy and Nutritional Status, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant women of reproductive age in Bangladesh. The primary objective of the study is to identify a dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D status of the mother and infant. Read more about this study

Who is it for?
Ages 18 to 34 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Nutritional Status, Vitamin D
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteBangladesh
Study dates
Jul 2009to Jun 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 34 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy women, age 18 to < 35 years, who are clients at the Shimantik clinic or friends/relatives of Shimantik clients.
  • Current permanent residence in Dhaka at a fixed address, and have plans to stay in Dhaka for at least 4 months.
  • Pregnant women: Enrolled between 26th and 30th week of gestation (participants enrolled in 26th week will not start on-study until the 27th week or later), with a normal medical and obstetric history. Gestational age will be estimated based on the first day of the last menstrual period (LMP).
  • Informed consent provided after having an opportunity to consult with husband and/or family members.

Who cannot join

  • Current self-reported use of any non-food-based dietary supplements containing vitamin D (i.e., commercial micronutrient pills or capsules containing vitamin D).
  • Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
  • Severe anemia (hemoglobin concentration < 70 g/L).
  • Hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg on at least two measurements).
  • In pregnant women: previous history of giving birth to an infant with congenital anomalies.
  • In non-pregnant women: currently breast-feeding.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • SHIMANTIK Maternity Centre

    Dhaka, Dhaka Division

Other trials in Bangladesh

About this study

Official title: Antenatal Vitamin D Supplementation to Improve Neonatal Health Outcomes in Dhaka, Bangladesh: Preliminary Dose-finding and Safety Study

This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant women of reproductive age in Bangladesh. The primary objective of the study is to identify a dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D status of the mother and infant.

Read the detailed description

Vitamin D deficiency is common among pregnant and non-pregnant Bangladeshi women. The consequences of vitamin D deficiency during pregnancy are unknown, but increasing evidence suggests it may compromise fetal growth and development of the immune system. We hypothesize that vitamin D deficiency in pregnant women has an adverse effect on the newborn's defenses against infectious diseases in early infancy, and thus contributes to the high rates of neonatal mortality in South Asia. Randomized controlled trials of antenatal vitamin D supplementation are needed to test this hypothesis. However, preliminary studies are first necessary to establish a safe and efficacious dose of vitamin D to be used in such trials. In the proposed study, we will measure the response of the 25-hydroxyvitamin D serum concentration (a biomarker of vitamin D status) to oral vitamin D3 supplementation in pregnant women and non-pregnant women of reproductive age. The goal is to establish a safe, efficacious and feasible weekly vitamin D supplementation regimen for use in future trials. Five groups of approximately 15 women (3 groups of pregnant and 2 groups of non-pregnant women; total up to 75 women) will be supplemented and followed closely for 10 weeks (non-pregnant women) or until delivery (pregnant participants). The primary outcomes will be the change in 25-hydroxyvitamin D concentrations following vitamin D supplementation, and safety parameters that reflect calcium regulation (serum albumin-adjusted calcium concentrations and urine calcium excretion) and fetal development.

Being tested
Vitamin D3
Keywords
pharmacokinetics, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Dietary supplement

    Also called Cholecalciferol, Vigantol Oil

    Vitamin D3 oral liquid 70,000 IU once

  • Vitamin D3Dietary supplement

    Also called Cholecalciferol, Vigantol Oil

    Vitamin D3 oral liquid 70,000 IU as loading dose, then 35,000 IU weekly thereafter for 10 weeks (non-pregnant) or until delivery (pregnant)

  • Vitamin D3Dietary supplement

    Also called Cholecalciferol, Vigantol Oil

    Vitamin D3 14,000 IU per week by mouth, starting at 27-30 weeks gestation and continued until delivery.

Study groups in NCT00938600
Study groupRoleWhat they receive
A1 - non-pregnant single-doseExperimentalNot described
Receives: Dietary Supplement: Vitamin D3
A2 - non-pregnant; weekly doseExperimentalNot described
Receives: Dietary Supplement: Vitamin D3
B1 - pregnant; single-doseExperimentalNot described
Receives: Dietary Supplement: Vitamin D3
B2 - pregnant; weekly doseExperimentalNot described
Receives: Dietary Supplement: Vitamin D3
C1 - active control; pregnant womenActive comparatorNot described
Receives: Dietary Supplement: Vitamin D3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 25-hydroxyvitamin D concentration

    Measured: 6 scheduled timepoints during supplementation period

  2. Serum calcium concentration (albumin-corrected)

    Measured: 6 scheduled timepoints during supplementation period

  3. Urine calcium: creatinine ratio

    Measured: 7-8 scheduled timepoints during supplementation period

Secondary outcomes (6)

  1. Blood pressure

    Measured: Weekly during supplementation period

  2. Urinary protein excretion

    Measured: Weekly during supplementation period

  3. Maternal weight

    Measured: Weekly during supplementation period

  4. Birth anthropometry

    Measured: At birth

  5. Neonatal echocardiography

    Measured: Neonatal period

  6. Fetal LL-37 expression/secretion in saliva, vernix, and cord tissue

    Measured: Birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00938600
Sponsor's protocol ID
JHU-1819
Acronym
AViDD-1
Status last verified
Aug 2012
First submitted
13 Jul 2009
Last updated
17 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Islam MZ, Shamim AA, Kemi V, Nevanlinna A, Akhtaruzzaman M, Laaksonen M, Jehan AH, Jahan K, Khan HU, Lamberg-Allardt C. Vitamin D deficiency and low bone status in adult female garment factory workers in Bangladesh. Br J Nutr. 2008 Jun;99(6):1322-9. doi: 10.1017/S0007114508894445.

    PubMed 18430266

  • Islam MZ, Lamberg-Allardt C, Karkkainen M, Outila T, Salamatullah Q, Shamim AA. Vitamin D deficiency: a concern in premenopausal Bangladeshi women of two socio-economic groups in rural and urban region. Eur J Clin Nutr. 2002 Jan;56(1):51-6. doi: 10.1038/sj.ejcn.1601284.

    PubMed 11840180

  • Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

    PubMed 39077939

  • Roth DE, Al Mahmud A, Raqib R, Black RE, Baqui AH. Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women. Nutr J. 2012 Dec 27;11:114. doi: 10.1186/1475-2891-11-114.

    PubMed 23268736

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin D3 in people with Pregnancy and Nutritional Status, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

25-hydroxyvitamin D concentration (time frame: 6 scheduled timepoints during supplementation period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00938600, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.

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Antenatal Vitamin D3 Dose-finding and Safety Study | AzTrials