Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial
1 other identifier
interventional
350
1 country
1
Brief Summary
The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the study participants will receive Vitamin D in supplement form. Pregnant women will be individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till the time of delivery.A blood sample will also be collected from the participant at the time of recruitment /before the starting of the supplementation for the assessment of Calcium, Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D level to assess vitamin D status will be done after completion of the supplementation phase at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan University laboratory
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Jun 2013
Typical duration for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJuly 18, 2016
July 1, 2016
2.1 years
August 6, 2014
July 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pregnancy out come
Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.
At delivery of neonate
Secondary Outcomes (1)
Prevalence of vitamin D deficiency in pregnant women
at recruitment into study (first trimester)
Study Arms (3)
Intervention Group
ACTIVE COMPARATORArm 1 is receiving vitamin D supplementation in 2000 IU/day ,
Arm 2 intervention group
ACTIVE COMPARATORArm 2 is receiving vitamin D supplementation in 4000/IU per day
Arm 3 control group
ACTIVE COMPARATORArm 3 is receiving vitamin D supplementation in 400 IU/day
Interventions
comparison of different dosages of vitamin D
Eligibility Criteria
You may qualify if:
- Pregnant women aged 15 - 45 years
- Less than 16 weeks pregnant from Last menstrual period.
- Agree to take part in this study, will be enrolled.
You may not qualify if:
- Pregnant women with pre existing type 1 or type II diabetes,
- Pregnant women with pre existing hypertension
- Women with multiple fetuses, babies (twins, triplets)
- Women with fetal anomaly in scan
- Refuse to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aga Khan University
Karachi, Sindh, 75300, Pakistan
Related Publications (6)
Farrant HJ, Krishnaveni GV, Hill JC, Boucher BJ, Fisher DJ, Noonan K, Osmond C, Veena SR, Fall CH. Vitamin D insufficiency is common in Indian mothers but is not associated with gestational diabetes or variation in newborn size. Eur J Clin Nutr. 2009 May;63(5):646-52. doi: 10.1038/ejcn.2008.14. Epub 2008 Feb 20.
PMID: 18285809RESULTBodnar LM, Catov JM, Roberts JM, Simhan HN. Prepregnancy obesity predicts poor vitamin D status in mothers and their neonates. J Nutr. 2007 Nov;137(11):2437-42. doi: 10.1093/jn/137.11.2437.
PMID: 17951482RESULTJavaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.
PMID: 16399151RESULTGale CR, Robinson SM, Harvey NC, Javaid MK, Jiang B, Martyn CN, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and child outcomes. Eur J Clin Nutr. 2008 Jan;62(1):68-77. doi: 10.1038/sj.ejcn.1602680. Epub 2007 Feb 21.
PMID: 17311057RESULTPalacios 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: 39077939DERIVEDNausheen S, Habib A, Bhura M, Rizvi A, Shaheen F, Begum K, Iqbal J, Ariff S, Shaikh L, Raza SS, Soofi SB. Impact evaluation of the efficacy of different doses of vitamin D supplementation during pregnancy on pregnancy and birth outcomes: a randomised, controlled, dose comparison trial in Pakistan. BMJ Nutr Prev Health. 2021 Sep 27;4(2):425-434. doi: 10.1136/bmjnph-2021-000304. eCollection 2021.
PMID: 35028513DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sidrah Nausheen, FCPS
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 13, 2014
Study Start
June 1, 2013
Primary Completion
July 1, 2015
Study Completion
January 1, 2016
Last Updated
July 18, 2016
Record last verified: 2016-07