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

July 15, 2016 updated by: Dr Sidrah Nausheen, Aga Khan University

Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75300
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Brand name: Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy out come
Time Frame: At delivery of neonate
Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.
At delivery of neonate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of vitamin D deficiency in pregnant women
Time Frame: at recruitment into study (first trimester)
Maternal vitamin D deficiency in the target group.
at recruitment into study (first trimester)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF8/0911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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