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NCT Number: NCT02215213

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

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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Key information

Conditions

Pregnancy

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 75300, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D supplement

Drug

comparison of different dosages of vitamin D

Other names: Brand name: Vitamin D3, LOT ID AKUH COMPOUNDING 2305012014

Primary outcomes

  1. pregnancy out come

    Time frame: At delivery of neonate

    Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 13, 2014
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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