Skip to content

The effect of oral high-micronutrient nutritional supplements on lipid profile in underweight hypertensive pregnant women

Effects of multiple micronutrient nutritional supplementation on cardio-metabolic biomarkers of pre-eclamptic women: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15485068
Enrollment
60
Registered
2018-04-21
Start date
2018-04-15
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Preeclampsia Pregnancy and Childbirth

Interventions

Participants are identified from antenatal units of tertiary care hospitals of Peshawar and study aims and objectives are explained to them. Each participant is screened for eligibility criteria and i

Sponsors

Khyber Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Primigravida after 20 weeks of gestation with the sign and symptoms (hypertension, proteinuria and edema) of preeclampsia. 2. Female aged 15 to 35 years. 3. Under-weight preeclamptic with BMI = <18.5 kg/m2 at first antenatal visit from antenatal record.

Exclusion criteria

Exclusion criteria: 1. Normal pregnant women 2. Past history of hypertension, essential hypertension, diabetes mellitus, renal disorders, liver disorders. 3. Previously on long medications 4. Any history of GIT disease, surgery or any eating disorder like bulimia nervosa, anorexia nervosa and purging disorders.

Design outcomes

Primary

MeasureTime frame
1. Lipid profile is analysed from a blood sample by using cobas C3 analyzer at baseline, delivery and 6 months post-delivery. 2. Apo A , Apo B and LPA measured from a blood sample using electrochemiluminescence technique by Modular E411 Roche at baseline, delivery and 6 months post-delivery. 3. Insulin and insulin growth factor is analysed from a blood sample by ELISA at baseline, delivery and 6 months post-delivery. 4. Insulin resistance is measured using formula (HOMA (IR) = Fasting glucose *Fasting insulin/22.5) at baseline, delivery and 6 months post delivery. 5. Urine Albumen is detected using dipstick method at baseline, delivery and 6 months post-delivery. 6. Patient outcome measures are the mode of delivery (normal vaginal delivery, assisted vaginal delivery, cesarean section) and (full term, premature, stillbirth etc) assessed by reviewing patient notes from the hospital and their medical test at baseline on time of recruitment after 20 weeks of gestation , at their stay in hospital on time of delivery from the mother and their baby and 6 months after delivery from both mother and babies. 7. Hr-troponin and blood glucose levels are analysed from baby cord blood at delivery (baseline) and 6 months.

Secondary

MeasureTime frame
1. Energy intake is calculated by win diet 2005 software after the intake of supplements. 2. Appetite is measured using validated questionnaires after the intake of supplements. 3. Compliance to the supplement is measured by the empty sachet and leftovers 4. Satisfaction is measured using the following questions: 4.1. Are you satisfied by MAMMTA? 4.2. Will you be happy to use MAMMTA in your next pregnancy?

Countries

Pakistan

Contacts

Public ContactNabila Sher Mohammad

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026