Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01060735
First received: January 31, 2010
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.

We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.

The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.


Condition Intervention
Healthy
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS). [ Time Frame: Bone status in offsprings, assessed at the age of one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vitamin D status of mothers. [ Time Frame: At the start of intervention, at delivery and at the age of one year ] [ Designated as safety issue: Yes ]
  • Maternal health status. [ Time Frame: At the start of intervention, at delivery and at the age of one year ] [ Designated as safety issue: Yes ]
  • Infants' growth. [ Time Frame: At the start of intervention, at delivery and at the age of one year ] [ Designated as safety issue: Yes ]
  • Vitamin D status in infants. [ Time Frame: At the start of intervention, at delivery and at the age of one year ] [ Designated as safety issue: Yes ]
  • Safety of vitamin D supplementation doses. [ Time Frame: At the start of intervention, at delivery and at the age of one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Larger doses of vitamin D supplementation
The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day
Dietary Supplement: Vitamin D
Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery
No Intervention: Conventional vitamin D supplementation
Regular supplementation during pregnancy with 400IU vitamin D

Detailed Description:

This is a prospective randomized controlled study.

120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.

25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.

25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.

Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.

Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.

Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy pregnant women aged 20 to 40 years, of any parity status.
  • Signed informed consent

Exclusion Criteria:

  • Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders
  • Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060735

Contacts
Contact: Corina Hartman, MD 972-3-9253674 corinah@clalit.org.il
Contact: Raanan Shamir, Professor 972-3-9253673 raanans@clalit.org.il

Locations
Israel
Schneider Children's Medical Center of Israel Recruiting
Petah Tikva, Israel, 49202
Sub-Investigator: Raanan Shamir, Professor         
Sub-Investigator: Eran Adar, MD         
Sub-Investigator: Moshe Hod, Professor         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Corina Hartman, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Corina Hartman, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01060735     History of Changes
Other Study ID Numbers: rmc005437ctil
Study First Received: January 31, 2010
Last Updated: July 21, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Rabin Medical Center:
Vitamin D
pregnancy
children
bone
quantitative ultrasound
Healthy pregnant women

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

ClinicalTrials.gov processed this record on August 25, 2014