Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215213
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Sidrah Nausheen, Aga Khan University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Vitamin D supplement Not Applicable

Detailed Description:
The investigators hypothesize that Pakistani mothers as darkly pigmented, will require substantially higher oral supplementation with vitamin D to replenish the micronutrient stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D deficiency. The investigators expect that if vitamin D is supplemented to pregnant women, their newborn infants would inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double blinded trial, study participants divided into three groups which will receive Vitamin D supplementation in 400, 2000 and 4000 International Units. The group which will receive 400 IUs will be treated as control group.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy
Study Start Date : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Intervention Group
Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,
 Drug: Vitamin D supplement
comparison of different dosages of vitamin D
Other Names:
  • Brand name: Vitamin D3
  • LOT ID AKUH COMPOUNDING 2305012014

Drug: Vitamin D supplement
comparison of different dosages of vitamin D Supplement
Other Name: Brand name: Vitamin D3
Active Comparator: Arm 2 intervention group
Arm 2 is receiving vitamin D supplementation in 4000/IU per day
 Drug: Vitamin D supplement
comparison of different dosages of vitamin D
Other Names:
  • Brand name: Vitamin D3
  • LOT ID AKUH COMPOUNDING 2305012014

Drug: Vitamin D supplement
comparison of different dosages of vitamin D Supplement
Other Name: Brand name: Vitamin D3
Active Comparator: Arm 3 control group
Arm 3 is receiving vitamin D supplementation in 400 IU/day
 Drug: Vitamin D supplement
comparison of different dosages of vitamin D
Other Names:
  • Brand name: Vitamin D3
  • LOT ID AKUH COMPOUNDING 2305012014

Drug: Vitamin D supplement
comparison of different dosages of vitamin D Supplement
Other Name: Brand name: Vitamin D3


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. pregnancy out come [ Time Frame: At delivery of neonate ]
    Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.


Secondary Outcome Measures :
  1. Prevalence of vitamin D deficiency in pregnant women [ Time Frame: at recruitment into study (first trimester) ]
    Maternal vitamin D deficiency in the target group.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215213


Locations
Layout table for location information
Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 75300
Sponsors and Collaborators
Aga Khan University
Investigators
Layout table for investigator information
Principal Investigator: Sidrah Nausheen, FCPS Aga Khan University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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

Layout table for additonal information
Responsible Party: Dr Sidrah Nausheen, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT02215213    
Other Study ID Numbers: PF8/0911
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Keywords provided by Dr Sidrah Nausheen, Aga Khan University:
Vitamin D
pregnancy
Pakistan
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
 Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents