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

Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02215213
Enrollment
350
Registered
2014-08-13
Start date
2013-06-30
Completion date
2016-01-31
Last updated
2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Vitamin D, pregnancy, Pakistan

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.

Interventions

comparison of different dosages of vitamin D

Sponsors

Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pregnancy out comeAt delivery of neonateHypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.

Secondary

MeasureTime frameDescription
Prevalence of vitamin D deficiency in pregnant womenat recruitment into study (first trimester)Maternal vitamin D deficiency in the target group.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026