Assessment of Dose Effectiveness of Vitamin D Supplementa... | NCT02215213

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

NCT02215213

Sponsor

Aga Khan University

Status

Completed

Last Update Posted

Jul 18, 2016Estimated

Enrollment

350Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Vitamin D supplement
Vitamin D supplement

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Aug 6, 2014

First Submission Date that Met QC Criteria

Aug 12, 2014

First Posted Date

Aug 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2016

Last Update Posted Date

Jul 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Sidrah Nausheen, Principal Investigator, Aga Khan UniversityPrincipal Investigator

Lead Sponsor

Aga Khan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Active Comparator	Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,	Drug: Vitamin D supplement
Arm 2 intervention group	Active Comparator	Arm 2 is receiving vitamin D supplementation in 4000/IU per day	Drug: Vitamin D supplement
Arm 3 control group	Active Comparator	Arm 3 is receiving vitamin D supplementation in 400 IU/day	Drug: Vitamin D supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D supplement	Drug	comparison of different dosages of vitamin D	Arm 2 intervention group Arm 3 control group Intervention Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sidrah Nausheen, FCPS	Aga Khan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aga Khan University		Karachi	Sindh	75300	Pakistan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18285809	Result	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.
17951482	Result