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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention Group

Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,

Group Type ACTIVE_COMPARATOR

Vitamin D supplement

Intervention Type DRUG

comparison of different dosages of vitamin D

Vitamin D supplement

Intervention Type DRUG

comparison of different dosages of vitamin D Supplement

Arm 2 intervention group

Arm 2 is receiving vitamin D supplementation in 4000/IU per day

Group Type ACTIVE_COMPARATOR

Vitamin D supplement

Intervention Type DRUG

comparison of different dosages of vitamin D

Vitamin D supplement

Intervention Type DRUG

comparison of different dosages of vitamin D Supplement

Arm 3 control group

Arm 3 is receiving vitamin D supplementation in 400 IU/day

Group Type ACTIVE_COMPARATOR

Vitamin D supplement

Intervention Type DRUG

comparison of different dosages of vitamin D

Vitamin D supplement

Intervention Type DRUG

comparison of different dosages of vitamin D Supplement

Interventions

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Vitamin D supplement

comparison of different dosages of vitamin D

Intervention Type DRUG

Vitamin D supplement

comparison of different dosages of vitamin D Supplement

Intervention Type DRUG

Other Intervention Names

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Brand name: Vitamin D3 LOT ID AKUH COMPOUNDING 2305012014 Brand name: Vitamin D3

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes