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Antenatal Vitamin D3 Dose-finding and Safety Study (AViDD-1)

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00938600
First received: July 13, 2009
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pregnancy
Nutritional Status
Vitamin D
 Dietary Supplement: Vitamin D3
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antenatal Vitamin D Supplementation to Improve Neonatal Health Outcomes in Dhaka, Bangladesh: Preliminary Dose-finding and Safety Study

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 25-hydroxyvitamin D concentration [ Time Frame: 6 scheduled timepoints during supplementation period ] [ Designated as safety issue: Yes ]
  • Serum calcium concentration (albumin-corrected) [ Time Frame: 6 scheduled timepoints during supplementation period ] [ Designated as safety issue: Yes ]
  • Urine calcium: creatinine ratio [ Time Frame: 7-8 scheduled timepoints during supplementation period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Weekly during supplementation period ] [ Designated as safety issue: No ]
  • Urinary protein excretion [ Time Frame: Weekly during supplementation period ] [ Designated as safety issue: No ]
  • Maternal weight [ Time Frame: Weekly during supplementation period ] [ Designated as safety issue: No ]
  • Birth anthropometry [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
  • Neonatal echocardiography [ Time Frame: Neonatal period ] [ Designated as safety issue: Yes ]
  • Fetal LL-37 expression/secretion in saliva, vernix, and cord tissue [ Time Frame: Birth ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 - non-pregnant single-dose Dietary Supplement: Vitamin D3
Vitamin D3 oral liquid 70,000 IU once
Other Names:
  • Cholecalciferol
  • Vigantol Oil
Experimental: A2 - non-pregnant; weekly dose Dietary Supplement: Vitamin D3
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)
Other Names:
  • Cholecalciferol
  • Vigantol Oil
Experimental: B1 - pregnant; single-dose Dietary Supplement: Vitamin D3
Vitamin D3 oral liquid 70,000 IU once
Other Names:
  • Cholecalciferol
  • Vigantol Oil
Experimental: B2 - pregnant; weekly dose Dietary Supplement: Vitamin D3
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)
Other Names:
  • Cholecalciferol
  • Vigantol Oil
Active Comparator: C1 - active control; pregnant women Dietary Supplement: Vitamin D3
Vitamin D3 14,000 IU per week by mouth, starting at 27-30 weeks gestation and continued until delivery.
Other Names:
  • Cholecalciferol
  • Vigantol Oil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938600

Locations
Bangladesh
SHIMANTIK Maternity Centre
Dhaka, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins University
Investigators
Principal Investigator: 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
Study Director: Daniel E Roth, MD The Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abdullah Baqui, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00938600     History of Changes
Other Study ID Numbers: JHU-1819
Study First Received: July 13, 2009
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board
Bangladesh: Ethical Review Committee

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
pharmacokinetics
safety

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 22, 2013