Antenatal Vitamin D3 Dose-finding and Safety Study

Pregnancy Clinical Trial

— AViDD-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938600
• Other study ID #: JHU-1819
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2009
• Last updated: August 16, 2012
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardBangladesh: Ethical Review Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nutritional Status
• Pregnancy
• Vitamin D

Intervention

Dietary Supplement:
• Vitamin D3
Vitamin D3 oral liquid 70,000 IU once
• 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)
• Vitamin D3
Vitamin D3 14,000 IU per week by mouth, starting at 27-30 weeks gestation and continued until delivery.

Locations

Country	Name	City	State
Bangladesh	SHIMANTIK Maternity Centre	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Johns Hopkins University

Country where clinical trial is conducted

Bangladesh, 

References & Publications (2)

Islam MZ, Lamberg-Allardt C, Kärkkäinen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D concentration		6 scheduled timepoints during supplementation period	Yes
Primary	Serum calcium concentration (albumin-corrected)		6 scheduled timepoints during supplementation period	Yes
Primary	Urine calcium: creatinine ratio		7-8 scheduled timepoints during supplementation period	Yes
Secondary	Blood pressure		Weekly during supplementation period	No
Secondary	Urinary protein excretion		Weekly during supplementation period	No
Secondary	Maternal weight		Weekly during supplementation period	No
Secondary	Birth anthropometry		At birth	Yes
Secondary	Neonatal echocardiography		Neonatal period	Yes
Secondary	Fetal LL-37 expression/secretion in saliva, vernix, and cord tissue		Birth	No