Antenatal Vitamin D3 Dose-finding and Safety Study

NCT00938600 | Completed Phase 1 DMC

• 1 other identifier: JHU-1819
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Nutritional Status; Vitamin D

Keywords

pharmacokinetics; safety

Outcome Measures

Primary Outcomes (3)

• 25-hydroxyvitamin D concentration

  6 scheduled timepoints during supplementation period

• Serum calcium concentration (albumin-corrected)

  6 scheduled timepoints during supplementation period

• Urine calcium: creatinine ratio

  7-8 scheduled timepoints during supplementation period

Secondary Outcomes (6)

• Blood pressure

  Weekly during supplementation period

• Urinary protein excretion

  Weekly during supplementation period

• Maternal weight

  Weekly during supplementation period

• Birth anthropometry

  At birth

• Neonatal echocardiography

  Neonatal period

Study Arms (5)

A1 - non-pregnant single-dose

EXPERIMENTAL

Dietary Supplement: Vitamin D3

A2 - non-pregnant; weekly dose

EXPERIMENTAL

Dietary Supplement: Vitamin D3

B1 - pregnant; single-dose

EXPERIMENTAL

Dietary Supplement: Vitamin D3

B2 - pregnant; weekly dose

EXPERIMENTAL

Dietary Supplement: Vitamin D3

C1 - active control; pregnant women

ACTIVE COMPARATOR

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 oral liquid 70,000 IU once

Also known as: Cholecalciferol, Vigantol Oil

A1 - non-pregnant single-dose; B1 - pregnant; single-dose

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Johns Hopkins University: collaborator

Study Sites (1)

SHIMANTIK Maternity Centre

Dhaka, Dhaka Division, Bangladesh

Location

Related Publications (4)

• 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.

  PMID: 18430266 BACKGROUND

• 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.

  PMID: 11840180 BACKGROUND

• 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.

  PMID: 39077939 DERIVED

• 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.

  PMID: 23268736 DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Abdullah Baqui, MBBS

  The Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Rubhana Raqib, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

• Shams El Arifeen, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

• Daniel E Roth, MD

  The Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

BA (1)