Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age
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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 |
- 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 ]
- 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 |
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| Contact: Corina Hartman, MD | 972-3-9253674 | corinah@clalit.org.il |
| Contact: Raanan Shamir, Professor | 972-3-9253673 | raanans@clalit.org.il |
| 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 | |
| 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 Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013